Control Of Nausea Research Articles

Factors influencing length of stay after surgery for benign foregut disease.

Length of stay (LOS) is an important measure of quality and healthcare costs. Variation occurs due to individual and institutional practices, case complexity and patient/social factors. Identification of variables affecting LOS may help develop enhanced recovery protocols. This study aims to identify factors influencing LOS following surgery for hiatal hernia, gastro-oesophageal reflux and achalasia. We identified all patients who underwent benign foregut surgery between August 2013 and July 2014 inclusive. Data from a prospectively maintained database were collected and univariate/multivariable analyses were performed. All patients were contacted to determine their 30-day readmission rate to any hospital. One hundred and sixty-five patients were identified in the 12-month period; 68% underwent laparoscopic surgery and 32% open surgery. The rates of laparoscopic conversion to open surgery and operative mortality were zero. Statistically, the most significant predictor of LOS was the surgical approach. The median LOS was 2 days for laparoscopic surgery and 4 days for open surgery. Beyond the surgical approach, the following factors were significant in predicting LOS: for laparoscopic surgery patients, younger age, shorter operative time, nasogastric (NG) tube removal in the operation theatre (OT), OT exit before noon, low postoperative nausea counts and discharge to home rather than a skilled facility were associated with reduced LOS. For open surgery patients, younger age, American Society of Anesthesiologists grade I-II, urinary catheter removal before discharge, discharge to home and discharge on the weekend were associated with reduced LOS. Whether surgery was primary or reoperation did not affect LOS. The overall 30-day readmission rate was 5% (laparoscopic 3% and open 12%; P = 0.003). The laparoscopic surgery approach, where feasible, in the treatment of benign foregut diseases is the strongest predictor of a decreased LOS. Modifiable factors influencing LOS include OT exit time, NG tube removal in the OT, urinary catheter removal in hospital and postoperative nausea control. Any implementation of enhanced recovery pathways to optimize these factors must monitor readmission rates and complications to confirm efficacy.

Controlling chemotherapy-induced nausea requires further improvement: symptom experience and risk factors among Korean patients.

The purpose of the present study is to describe the incidence and intensity of chemotherapy-induced nausea and vomiting (CINV) and patterns of symptom change after chemotherapy among Korean cancer patients for whom antiemetic guidelines were widely utilized and guideline-consistent antiemetics were available. The study also aimed to determine the contribution of known risk factors for CINV to the incidence and intensity of CINV, as well as patterns of symptom change. A prospective observational descriptive study was conducted. A total of 332 adult cancer patients starting their first adjuvant chemotherapy participated in this study. Items of the Multinational Association of Supportive Care in Cancer Antiemesis Tool were utilized to generate a symptom diary. Descriptive statistics, logistic regression analyses, repeated measures ANOVA, and hierarchical generalized linear models were applied to analyze the data. Vomiting occurred, on average, less than once in the acute and delayed phases, and its frequency remained similar throughout 5days after chemotherapy infusion in the first and second cycles. A quadratic pattern of nausea change was found. Nausea intensity increased to a peak on the third day after chemotherapy infusion (first-cycle incidence rate ratio (IRR)=1.40 and second-cycle IRR=1.27, both p<.001) and then changed gradually (first-cycle IRR=0.69 and second-cycle and IRR=0.76, both p<.001). Nausea experience in the previous cycle contributed to the subsequent nausea intensity (IRR=2.78, p<.001). Younger age, consuming less alcohol, and expecting nausea were identified as risk factors for chemotherapy-induced nausea that needed to be considered from the start of the chemotherapy. Nausea control, especially in the delayed phase, has room for improvement. As the first chemotherapy-induced nausea experience contributes to subsequent symptom experience, intense control from the start of chemotherapy is necessary while considering patient-related risk factors. Future studies should evaluate the contribution of risk factors when antiemetic prophylaxis is fully provided in multiple settings.

Abstract P1-10-06: Nausea control and quality-of-life benefit with NEPA, the first combination antiemetic agent, in patients with breast cancer receiving anthracycline/cyclophosphamide (AC) chemotherapy

Abstract Background: Patients (pts) with breast cancer (BC) are at high risk for developing chemotherapy-induced nausea and vomiting (CINV) due to the emetogenicity of chemotherapy (often AC-based) and predisposing risk factors including young age and female gender. For pts receiving AC, antiemetic guidelines recommend prophylactic administration of an NK1 receptor antagonist (RA), a 5-HT3 RA, and dexamethasone (DEX). NEPA is the first fixed combination agent approved in oncology; comprised of a highly selective NK1 receptor antagonist (RA), netupitant (300 mg), and the pharmacologically/clinically distinct 5-HT3 RA, palonosetron (PALO 0.50 mg). NEPA has shown superior complete response (no emesis/no rescue use) rates compared with oral PALO in a Phase 3 trial in pts receiving AC (Aapro, Ann Oncol 2014) and in that study's BC subset. Despite progress in prevention of vomiting, nausea control remains suboptimal, particularly in the delayed phase (days 2-5), and debate exists whether NK1 RAs improve nausea control. The objective of this post-hoc analysis was to evaluate whether NEPA showed nausea and associated quality-of-life (QOL) benefits in the subset of patients with BC in this trial. Methods: The subset of chemotherapy-naïve BC pts from this multinational, randomized, double-blind Phase 3 study were included in this analysis. Patients received either a single dose of NEPA or oral PALO prior to AC along with oral DEX 12 mg (NEPA) or 20 mg (PALO). No significant nausea (NSN: max &amp;lt;25 mm on 100 mm visual analog scale) rates in the acute (0-24h), delayed (25-120h) and overall (0-120h) phases following chemotherapy during cycles 1-4 were calculated. QOL was assessed by the Functional Living Index—Emesis (FLIE) during cycle 1 overall phase; the percentage of pts with "no impact on daily life" (NIDL) was calculated. Comparisons between groups were performed using a Cochran-Maentel-Haenszel test. Results: 1412 patients with BC were included for a total of 5839 AC cycles. NSN rates were similar for both groups in the acute phase, superior for NEPA during cycles 1, 2 and 4 in the delayed phase, and superior for NEPA during cycles 1-4 in the overall phase. Overall NSN (0-120h)NEPA + DEXOral PALO + DEXP ValueCycle 174.2% (N = 708)68.5% (N = 704)0.016Cycle 277.0% (N = 621)71.1% (N = 636)0.015Cycle 378.2% (N = 586)72.7% (N = 594)0.027Cycle 479.9% (N = 542)74.9% (N = 550)0.040 This corresponded with a significantly greater proportion of NEPA patients reporting NIDL compared with PALO due to nausea (71% vs 65%; p=0.007) in cycle 1. Conclusions: While other NK1RAs have not consistently shown benefit in improving nausea control over 5-HT3RA + DEX, in this study NEPA significantly improved prevention of nausea over oral PALO in BC patients receiving AC. In addition, NEPA was superior to PALO in reducing the negative impact of nausea on patients' daily functioning. As the first fixed antiemetic drug combination, NEPA is highly effective and offers the convenience of a single dose administered with DEX on Day 1 only. Citation Format: Rugo HS, Aapro M, Rizzi G. Nausea control and quality-of-life benefit with NEPA, the first combination antiemetic agent, in patients with breast cancer receiving anthracycline/cyclophosphamide (AC) chemotherapy. [abstract]. In: Proceedings of the Thirty-Eighth Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2015 Dec 8-12; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2016;76(4 Suppl):Abstract nr P1-10-06.

End-of-life care pathways for improving outcomes in caring for the dying.

This is an updated version of a Cochrane review published in Issue 11, 2013 in the Cochrane Library. In many clinical areas, integrated care pathways are utilised as structured multidisciplinary care plans that detail essential steps in caring for patients with specific clinical problems. In particular, care pathways for the dying have been developed as a model to improve care of patients who are in the last days of life. The care pathways were designed with an aim of ensuring that the most appropriate management occurs at the most appropriate time, and that it is provided by the most appropriate health professional. Since the last update, there have been sustained concerns about the safety of implementing end-of-life care pathways, particularly in the United Kingdom (UK). Therefore, there is a significant need for clinicians and policy makers to be informed about the effects of end-of-life care pathways via a systematic review. To assess the effects of end-of-life care pathways, compared with usual care (no pathway) or with care guided by another end-of-life care pathway across all healthcare settings (e.g. hospitals, residential aged care facilities, community).In particular, we aimed to assess the effects on symptom severity and quality of life of people who are dying, or those related to the care, such as families, carers and health professionals, or a combination of these. We searched the Cochrane Central Register of Controlled Trials (CENTRAL; Cochrane Library; 2015, Issue 6), MEDLINE, EMBASE, PsycINFO, CINAHL, review articles, trial registries and reference lists of relevant articles. We conducted the original search in September 2009, and the second updated search in July 2015. All randomised controlled trials (RCTs), quasi-randomised trials or high quality controlled before-and-after studies comparing use versus non-use of an end-of-life care pathway in caring for the dying. Two review authors independently assessed the results of the searches against the predetermined criteria for inclusion, assessed risk of bias, and extracted data. We used standard methodological procedures expected by Cochrane. We screened 3028 titles, and included one Italian cluster RCT with 16 general medicine wards (inpatient units in hospitals) and 232 carers of cancer patients in this updated review. We judged the study to be at a high risk of bias overall, mainly due to a lack of blinding and rates of attrition. Only 34% of the participants (range 14% to 75% on individual wards) were cared for in accordance with the care pathway as planned. However, these issues were to be expected due to the nature of the intervention and condition. The study population was all cancer patients in their last days of life. Participants were allocated to care using the Liverpool Care Pathway (LCP-I, Italian version of a continuous quality improvement programme of end-of-life care) or to standard care. The primary outcomes of this review were physical symptom severity, psychological symptom severity, quality of life, and any adverse effects. Physical symptom severity was assessed as overall control of pain, breathlessness, and nausea and vomiting. There was very low quality evidence of a difference in overall control of breathlessness that favoured the Liverpool Care Pathway group compared to usual care: the study reported an odds ratio (OR) of 2.0 with 95% confidence intervals (CIs) 1.1 to 3.8. Very low quality evidence of no difference was found for pain (OR 1.3, 95% CI 0.7 to 2.6, P = 0.461) and nausea and vomiting (OR 1.5, 95% CI 0.7 to 3.2, P = 0.252). None of the other primary outcomes were assessed by the study. Limited data on advance care planning were collected by the study authors, making results for this secondary outcome unreliable. None of our other secondary outcomes were assessed by the study. There is limited available evidence concerning the clinical, physical, psychological or emotional effectiveness of end-of-life care pathways.

30-day readmissions after sleeve gastrectomy versus Roux-en-Y gastric bypass

BackgroundLaparoscopic sleeve gastrectomy (SG) is gaining popularity over laparoscopic Roux-en-Y gastric bypass (LRYGB) within the United States. Data on readmissions after bariatric procedures are mostly based on LRYGB, with limited evidence regarding etiology of readmissions after SG. ObjectivesThe aim of this study was to compare 30-day readmission rate and etiology after SG and LRYGB. SettingAmerican College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) participating facilities MethodsPatients undergoing elective laparoscopic SG and LRYGB in 2012 and 2013 were identified from the ACS-NSQIP Participant Use Data File. Demographic characteristics, co-morbidities, and 30-day readmissions were analyzed. Multivariable logistic regression analysis evaluated variables with P<.1, using readmission as the dependent variable. ResultsA total of 34,983 patients underwent bariatric surgery (46.0% SG, 54.0% LRYGB). Readmission was reported in 1773 (5.1%) patients. Readmission was more common after LRYGB compared with SG (6.1% versus 3.8%, P<.001, adjusted OR 1.59, 95% CI 1.44–1.76, P<.001). Nausea, vomiting, and dehydration were more commonly a reason for readmission after SG than LRYGB (30.4% versus 18.8%, P =<.001). Additionally, venous thromboembolism was a more frequent readmission cause for SG compared with LRYGB patients (7.2% versus 3.6%, P = .002). Postoperative pain, bleeding, intestinal obstructions, and wound occurrences were more commonly a readmission cause for LRYGB compared with SG. ConclusionsHospital readmissions are more common after LRYGB than SG. Reasons for readmission differ between procedures. Given the progressive increase in the proportion of bariatric patients undergoing SG, hospital programs that aim to decrease readmissions after bariatric surgery need to focus on prevention and control of postoperative nausea and dehydration.

Antiemetic medication for prevention and treatment of chemotherapy-induced nausea and vomiting in childhood.

Nausea and vomiting remain a problem for children undergoing treatment for malignancies despite new antiemetic therapies. Optimising antiemetic regimens could improve quality of life by reducing nausea, vomiting, and associated clinical problems. This is an update of the original systematic review. To assess the effectiveness and adverse events of pharmacological interventions in controlling anticipatory, acute, and delayed nausea and vomiting in children and young people (aged less than 18 years) about to receive or receiving chemotherapy. Searches included the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, LILACS, PsycINFO, conference proceedings of the American Society of Clinical Oncology, International Society of Paediatric Oncology, Multinational Association of Supportive Care in Cancer, and ISI Science and Technology Proceedings Index from incept to December 16, 2014, and trial registries from their earliest records to December 2014. We examined references of systematic reviews and contacted trialists for information on further studies. We also screened the reference lists of included studies. Two review authors independently screened abstracts in order to identify randomised controlled trials (RCTs) that compared a pharmacological antiemetic, cannabinoid, or benzodiazepine with placebo or any alternative active intervention in children and young people (less than 18 years) with a diagnosis of cancer who were to receive chemotherapy. Two review authors independently extracted outcome and quality data from each RCT. When appropriate, we undertook meta-analysis. We included 34 studies that examined a range of different antiemetics, used different doses and comparators, and reported a variety of outcomes. The quality and quantity of included studies limited the exploration of heterogeneity to narrative approaches only.The majority of quantitative data related to the complete control of acute vomiting (27 studies). Adverse events were reported in 29 studies and nausea outcomes in 16 studies.Two studies assessed the addition of dexamethasone to 5-HT3 antagonists for complete control of vomiting (pooled risk ratio (RR) 2.03; 95% confidence interval (CI) 1.35 to 3.04). Three studies compared granisetron 20 mcg/kg with 40 mcg/kg for complete control of vomiting (pooled RR 0.93; 95% CI 0.80 to 1.07). Three studies compared granisetron with ondansetron for complete control of acute nausea (pooled RR 1.05; 95% CI 0.94 to 1.17; 2 studies), acute vomiting (pooled RR 2.26; 95% CI 2.04 to 2.51; 3 studies), delayed nausea (pooled RR 1.13; 95% CI 0.93 to 1.38; 2 studies), and delayed vomiting (pooled RR 1.13; 95% CI 0.98 to 1.29; 2 studies). No other pooled analyses were possible.Narrative synthesis suggests that 5-HT3 antagonists are more effective than older antiemetic agents, even when these agents are combined with a steroid. Cannabinoids are probably effective but produce frequent side effects. Our overall knowledge of the most effective antiemetics to prevent chemotherapy-induced nausea and vomiting in childhood is incomplete. Future research should be undertaken in consultation with children, young people, and families that have experienced chemotherapy and should make use of validated, age-appropriate measures. This review suggests that 5-HT3 antagonists are effective in patients who are to receive emetogenic chemotherapy, with granisetron or palonosetron possibly better than ondansetron. Adding dexamethasone improves control of vomiting, although the risk-benefit profile of adjunctive steroid remains uncertain.

Anxiety, pain, and nausea during the treatment of standard-risk childhood acute lymphoblastic leukemia: A prospective, longitudinal study from the Children's Oncology Group.

This prospective study describes the procedure-related anxiety, treatment-related anxiety, pain, and nausea experienced by children with standard-risk acute lymphoblastic leukemia (ALL) during the first year of treatment. This study was undertaken at 31 Children's Oncology Group (COG) sites. Eligible children who were 2 to 9.99 years old were enrolled in a COG trial for patients with newly diagnosed standard-risk ALL from 2005 to 2009. Parents completed a demographic survey at the baseline and the Pediatric Quality of Life Inventory 3.0 Cancer Module (proxy version) and the General Functioning Scale of the Family Assessment Device 1, 6, and 12 months after the diagnosis. The association between patient-related (age, sex, ethnicity, and treatment), parent-related (marital status and education), and family-related factors (functioning, income, and size) and symptom scores was evaluated. The mean scores for procedure-related anxiety, treatment-related anxiety, and pain improved during the first year of treatment (P < .0389). The mean nausea score was poorer 6 months after the diagnosis in comparison with the other assessments (P = .0085). A younger age at diagnosis was associated with significantly worse procedure-related anxiety (P = .004). An older age (P = .0002) and assignment to the intensified consolidation study arm (P = .02) were associated with significantly worse nausea. Children with ALL experienced decreasing treatment-related anxiety, procedure-related anxiety, and pain during the first year of treatment. In comparison with scores at 1 and 12 months, nausea was worse 6 months after the diagnosis. Minimization of procedure-related anxiety in younger children and improved nausea control in older children and those receiving more intensified treatment should be prioritized.

Comparison of the Control of Nausea and Vomiting among Several Moderately Emetic-Risk Chemotherapy Regimens.

Background: Different antiemetic medications with or without aprepitant are recommended for moderately emetic-risk chemotherapy (MEC) depending on the emetic potential of chemotherapy agents, although the criterion for the use of aprepitant is still unclear. The present study was designed to compare the control of chemotherapy-induced nausea and vomiting (CINV) among several MEC regimens used in the outpatient chemotherapy setting. Materials and Methods: A single center prospective observational study was carried out in 326 patients who received 2,061 chemotherapy cycles from January 2013 to December 2014. Antiemetic medication consisting of two-drug combination of granisetron (day 1) and dexamethasone (days 1-3) was carried out in 87.6% of patients receiving the first chemotherapy cycle. The checklist for CINV was provided to all patients, and the control of CINV was evaluated on the next visit based on the checklist. Complete inhibition of nausea and vomiting during acute and delayed periods were compared among MEC regimens. Results: Two hundred and one patients received the first cycle of chemotherapy, in which the rates of complete inhibition of nausea and vomiting were 87.6% and 95.5%, respectively, during acute period, and 68.2% and 92.0%, respectively, during delayed period. There were no significant differences in the control of CINV among oxaliplatin, carboplatin and irinotecan, except for the cyclophosphamide-base regimen.Conclusions: Two-drug antiemetic medication of 5-HT3 receptor antagonist and dexamethasone was sufficiently effective for prevention of CINV in most MEC regimens.

Dopamine: Receptors, Functions, Synthesis, Pathways, Locations and Mental Disorders: Review of Literatures

Dopamine is monoamine neurotransmitter. Dopamine is produced in the dopaminergic neurons in the ventral tegmental area of the substantia nigra, midbrain and the arcuate nucleus of the hypothalamus. In the periphery, dopamine is found in the kidney where it functions to produce renal vasodilation, diuresis, and natriuresis. Dopamine neurons are more widely distributed than those of other monamines and it is found in hypothalamus, olfactory bulb, the midbrain substantia nigra and ventral tegmental area and in the periaqueductal gray and retina. There are five subtypes of dopamine receptors, D1, D2, D3, D4, and D5, which are members of the large G-protein coupled receptor super family. The dopamine receptor subtypes are divided into two major subclasses: types 1 and 5 are similar in structure and drug sensitivity, and these two receptors are referred to as the D1like group or class of receptors. Dopamine receptor types 2, 3, and 4 are called the D2like group. Dopamine plays central role in pleasurable reward behavior, inhibition of prolactin production (involved in lactation), sleep, mood, attention, learning, behavior, control of nausea and vomiting and pain processing. In addition it also involved in controlling movement, emotion and cognition. Due to extensive localization of dopamine receptor to brain areas and its role in wide range of functions, dopaminergic dysfunction has been implicated in the pathophysiology of schizophrenia, mood disorders, obsessive compulsive disorder (OCD), autism spectrum disorders, attention deficit–hyperactivity disorder (ADHD), tourette's syndrome, substance dependency, Parkinson's disease and other disorders.

Effects of palonosetron and dexamethasone on postoperative nausea and vomiting in adult patients undergoing laparoscopic abdominal surgery: a randomized, double-blind, clinical trial at a tertiary care hospital

Background: Post-operative nausea and vomiting (PONV) is one of the common problems after laparoscopic abdominal surgery. It hampers the postoperative recovery in spite of the availability of many antiemetic drugs and regimens for its prevention. We evaluated the effectiveness of intravenous (IV) palonosetron in counteracting PONV during the first 48hrs following laparoscopic abdominal surgery, using dexamethasone as the comparator drug. Methods: In this study a single pre-induction IV doses of palonosetron (75mcg) or dexamethasone (8mg) were administered to adult patients of either sex undergoing elective laparoscopic abdominal surgery. There were 40 subjects per group. The pre-anesthetic regimen, anesthesia procedure and laparoscopic technique were uniform. The primary effectiveness measure was total number of PONV episodes in the 48 hours period following end of surgery. The frequencies of individual nausea, retching and vomiting episodes, visual analog scale (VAS) score for nausea at 2, 6, 12, 24 and 48 hours, use of rescue antiemetic (metoclopramide), number of complete responders (no PONV or use of rescue in 48 hours) and adverse events were secondary measures. SPSS software version 16 was employed to using student’s t-test, chi-square test or fisher’s exact tests. Value of P < 0.05 was considered significant. Results: The incidence of nausea and vomiting was maximal during the first six hours postoperatively. The complete control of postoperative nausea and vomiting for first 24 hours was achieved in 80% patients of palonosetron group and 60% patients of dexamethasone group. During 24-48 hours the incidence of PONV was 17.5% and 22.5% respectively in palonosetron group and dexamethasone group. The use of rescue medication is about 50% less in the use of palonosetron as antiemetic than dexamethasone. Safety profile was similar in both the groups. Conclusions: Palonosetron is comparatively highly effective to prevent the PONV after anaesthesia in elective laparoscopic abdominal surgery when administered as single pre-induction dose due to its prolonged duration of action than dexamethasone.

A Randomized Trial of Olanzapine and Palonosetron versus Infused Ondansetron for the Treatment of Chemotherapy Induced Nausea and Vomiting in Patients Undergoing Hematopoietic Stem Cell Transplantation

Background:Despite routine antiemetic administration during conditioning for hematopoietic stem cell transplantation (HSCT), breakthrough chemotherapy induced nausea and vomiting (CINV) can still be problematic. Recent studies in solid tumor therapy have demonstrated effectiveness of both olanzapine and the second generation 5HT3 receptor antagonist palonosetron in management of CINV. However, there remains little comparative data on efficacy of these agents, especially within HSCT.Aims:To compare the effectiveness of olanzapine and palonosetron to an ondansetron infusion (standard of care) for the treatment of breakthrough CINV in patients undergoing HSCT.Method:A randomized open-label prospective study was performed in HSCT patients suffering breakthrough CINV during conditioning despite standard prophylaxis with IV ondansetron 8mg TDS plus a single dose of oral aprepitant 165mg. Patients were randomised on a 1:1:1 basis to receive either ondansetron 32mg in 250ml normal saline as a continuous infusion over 24 hours, an olanzapine wafer 10mg once daily, or a single dose of palonosetron 0.25mg IV. All groups were allowed prn metoclopramide IV and / or lorazepam SL as rescue anti-nausea medication. Nausea score was graded from 0 (no nausea) to 100 (worst nausea) and recorded using a visual analogue scale (VAS). The primary endpoint was a composite outcome of no emesis, no use of rescue medication, and nausea score reduction of >50%. The secondary endpoint was nausea score reduction of >50%. Both endpoints were measure at 24 and 48hrs after initiation of the study treatment. Statistical analysis was conducted using a double-sided Fisher's exact test.Results:In total, 18, 22 and 22 patients were randomized to the ondansetron, olanzapine and palonosetron arms respectively. Overall 53% of patients had undergone autologous and 47% allogeneic HSCT. Conditioning regimens included high dose melphalan (200mg/m2) and BEAM for autologous HSCT and Cy / TBI and fludarabine / melphalan (melphalan 120mg/m2) for allogeneic protocols. A similar proportion of patients randomized to ondansetron versus olanzapine versus palonosetron received autologous versus allogeneic HSCT, with similar ratios of individual conditioning regimens included within each arm (p=NS for all comparisons). Patients' age, gender and other risk factors such as history of CINV were also similar between arms (p=NS for all comparisons). The primary endpoint was achieved in 6%, 45% and 18%, and 6%, 64% and 18% of ondansetron versus olanzapine versus palonosetron patient groups at 24 and 48hrs respectively. Overall olanzapine was significantly more effective at controlling breakthrough CINV compared to ondansetron at both 24 and 48hrs (p=0.011 and 0.0002 respectively). Olanzapine was also more effective than palonosetron at 48hrs (p=0.005). The secondary outcome was observed in 17%, 60% and 62%, and 35%, 71% and 43% of ondansetron versus olanzapine versus palonosetron patient groups at 24 and 48hrs respectively. Again, olanzapine was superior to ondansetron at controlling nausea at both 24 and 48hrs (p=0.0009 and p=0.048 respectively). However, there was no significant difference between olanzapine and palonosetron in reduction of nausea score >50% at either time point. Palonosetron was superior to ondansetron at nausea control at 24 (p=0.008) but not at 48hrs. Serious adverse drug reactions were not reported in any arms, and median duration from stem cell infusion to the engraftment was 13 days, 13 days and 14 days for ondansetron, olanzapine and palonosetron arms respectively (p=NS).Conclusions:When compared to ondansetron infusion and a single dose of palonosetron, daily olanzapine is superior treatment of breakthrough CINV in patients undergoing HSCT. A single dose of palonosetron does not significantly reduce emesis but is effective for the treatment of nausea up to 24 hours. Further studies are required to determine the ideal dosing frequency of palonosetron. DisclosuresOff Label Use: Olanzapine is used as an antiemetic, which is widely accepted..

QOL-16HEALTH-RELATED QUALITY OF LIFE (HRQoL) IN A PHASE II TRIAL OF HYPOFRACTIONATED INTENSITY-MODULATED RADIATION THERAPY (HYPO-IMRT) WITH TEMOZOLOMIDE (TMZ) AND BEVACIZUMAB (BEV) FOR PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA MULTIFORME (GBM)

BACKGROUND: The initial results of this phase II clinical trial revealed a six-month progression-free survival of 90%, median PFS of 15.9 months and median overall survival of 16.3 months. We report here HRQoL that was assessed as a correlative study. METHODS: HRQoL was assessed using the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire core-30 (QLQ-C30) and the EORTC brain cancer module (QLQ-BN20). Questionnaires were administered at baseline, completion of RT, 1 month post-RT, and every 3 months thereafter. Changes from baseline were calculated for each specific scale. A ≥ 10 point change in any scale from the mean baseline score was deemed significant. RESULTS: A total of 30 patients were treated on trial. HRQoL data was available for 28 patients (11 women; median age: 57 years [range, 31-72]; median KPS 80%). Compliance with assessments at baseline, completion of RT, 1 month post-RT, 3, 6, 9, and 12 months was 100, 96, 100, 86, 84, 52, and 30% respectively. Compared to baseline scores, there was no significant change in global health status, physical functioning, role functioning, emotional functioning, cognitive functioning or social functioning. No significant change was noted in nausea, pain, dyspnea, appetite, constipation, diarrhea, future uncertainty, visual disorder, communication deficit, headache, seizure, drowsiness or bladder control scores. Significant improvement was noted in financial, insomnia and fatigue scales. Significant worsening was noted in motor dysfunction, itchy skin, hair loss and weakness of legs. CONCLUSIONS: Treatment with hypo-IMRT combined with TMZ and BEV did not negatively impact overall HRQoL.

The Effect of Intravenous Dexamethasone on the Nausea Accompanying Vestibular Neuritis: A Preliminary Study

PurposeWe undertook a preliminary assessment of the efficacy of administering intravenous dexamethasone (DEX) for relieving the nausea and dizziness accompanying vestibular neuritis (VN). MethodsBetween November 2013 and October 2014, 26 patients with VN were prospectively enrolled in this study. The patients were randomly assigned to treatment with a combination of 20 mg/d of intravenous metoclopramide, 100 mg of oral dimenhydrinate, and 5 mg/d of intravenous DEX or 20 mg/d of intravenous metoclopramide, 100 mg of oral dimenhydrinate, and intravenous normal saline as a placebo therapy. Patients’ subjective assessments of the severity of their nausea and dizziness were recorded using a visual analog scale on the day of admission and 2 days, 3 days, 1 month, and 3 months thereafter. Bedside examinations consisted of spontaneous nystagmus (SPN) assessment, the head shaking nystagmus test, and the head impulse test, which were performed at every follow-up visit. FindingsThe severity of nausea and dizziness was significantly reduced over time (both P < 0.05). However, there was no significant effect of DEX injection on the severity of nausea or dizziness (P > 0.05). The presence of SPN was solely associated with nausea (hazard ratio = 3.34; 95% CI, 1.85–6.02). ImplicationsThe administration of intravenous DEX did not relieve nausea or dizziness any better than a placebo treatment. However, further research is required to confirm whether there is a dose-dependent effect of DEX on the control of nausea or dizziness in VN.

A comparison between palonosetron and ondansetron in prevention of postoperative nausea and vomiting after laparoscopic cholecystectomy

Postoperative nausea and vomiting (PONV) are common complications after anesthesia and surgery and is associated with adverse outcome. This study was designed to compare the effects of palonosetron and ondansetron in preventing PONV in patients with laparoscopic cholecystectomy. This prospective double-blind study included 60 female patients randomly assigned to the palonosetron group (n = 30) or the ondansetron group (n = 30). Palonosetron 0.075 mg was injected intravenously as a bolus in the palonosetron group. Ondansetron 8 mg was injected intravenously as a bolus in the ondansetron group. The incidences of nausea and vomiting and side effects was recorded after 30 min, 60 min, 2 hrs, 8hrs, 24 hrs postoperatively. The incidence of nausea and vomiting was maximal during immediate postoperative period particularly initial 4 hrs of postoperative period. The complete control of postoperative nausea and vomiting was seen in 30% patients of ondansetron group in first 12 hrs of postoperative period and 90% in palonosetron group. Safety profile was more with palonosetron. The effects of palonosetron and ondansetron in preventing PONV were compared in patients undergoing laparoscopic cholecystectomy and it was found that palonosetron was better in preventing postoperative nausea and vomiting.Mediscope Vol. 2, No. 2: July 2015, Pages 33-38

Control of chemotherapy-induced nausea in patients receiving outpatient cancer chemotherapy.

BackgroundControl of chemotherapy-induced nausea is still incomplete, regardless of adherence to the antiemetic guideline. The present study was designed to assess the control rates of nausea and vomiting in the outpatient chemotherapy clinic and to determine risk factors for nausea.MethodsA single-center prospective observational study was carried out in 779 patients who received 5511 chemotherapy cycles from January 2013 to December 2014 in the outpatient chemotherapy clinic. A checklist for adverse events was provided to all patients, and nausea and vomiting were monitored on the next visit. Complete protection from nausea and vomiting during acute (within 24 h) and delayed (during 2–7 days) periods was assessed.ResultsUnder the condition of 76–99 % rates of adherence to the Japanese Society of Clinical Oncology guideline for antiemesis, the rates of complete protection from acute and delayed nausea in the first cycle of chemotherapy were 60 % and 45 %, respectively, for high emetic risk chemotherapy (HEC), and 85 % and 70 % for moderate emetic risk chemotherapy (MEC). The rates were improved in the overall cycles. On the other hand, vomiting was well controlled, in which complete protection ranged from 83 % (HEC) to 99 % (minimum). A multivariate analysis indicated that being female, age less than 60 years, high or moderate risk chemotherapy, and anthracycline/cyclophosphamide (A/C) were significant risks for overall nausea. Indeed, the control of delayed nausea was extremely poor in the first cycle of A/C, although there was no difference in the control of nausea among MEC.ConclusionAntiemetic medication in consideration of the risk factors is required to improve the control of nausea.

Identifying an optimal antiemetic regimen for patients receiving anthracycline and cyclophosphamide-based chemotherapy for breast cancer--an inspection of the evidence base informing clinical decision-making.

Despite consensus recommendations for antiemetics in breast cancer patients receiving anthracycline and cyclophosphamide-based chemotherapy, control of chemotherapy-induced nausea and vomiting (CINV) remains sub-optimal. To inspect available evidence from randomized controlled trials (RCT) in this population to establish treatment comparisons that have been studied, outcomes that have been reported, and the extent of study heterogeneity. Review of this data helps identify challenges for a systematic review comparing antiemetic regimens, and to identify potential future trials. A search of Ovid MEDLINE®, Embase and Cochrane CENTRAL was performed. We sought RCTs comparing antiemetic regimens in breast cancer patients receiving anthracycline and cyclophosphamide-based chemotherapy. We extracted information related to study design, patient characteristics and interventions compared. Patterns of outcome reporting were studied. While performing network meta-analysis was also of interest, studies were judged highly heterogeneous and it was felt findings from such work would be of uncertain validity. From 1062 citations, a total of 30 full texts were retained. Overall, 47 antiemetic regimens were evaluated using 15 different CINV endpoints. Treatment comparisons were diverse and many were informed by single small trials. Reporting of key endpoints was varied and all endpoints were not consistently available. Heterogeneity in patients, chemotherapies administered, and intervention doses were noted. Despite the availability of consensus recommendations for antiemetic use, we identified challenges in synthesizing the evidence base including high diversity in treatment comparisons, varied outcome reporting, and study heterogeneity. These represent challenges to identifying an optimal antiemetic regimen. Future antiemetic trials should incorporate more informed comparator selection, report patient-oriented outcomes in a standard fashion, and provide accessible data for these measures.

Measuring the impact of guideline-based antiemetic therapy on nausea and vomiting control in breast cancer patients with multiple risk factors.

The objective of this exploratory analysis was to determine if individual patient risk factors could be used to optimize chemotherapy-induced nausea and vomiting (CINV). Through validated risk prediction models which quantify patient risk factors, 152 patients with early-stage breast cancer scheduled to received adjuvant anthracycline-based chemotherapy were categorized as being at low (level 0) or high-risk (level 1) for CINV. Prior to the first cycle of chemotherapy, low-risk patients received ondansetron and dexamethasone, while high-risk level 1 patients also received aprepitant. For subsequent cycles, patients who experienced CINV had their antiemetics changed in a stepwise manner to level 2 (extended-duration dexamethasone) or level 3 (extended-duration dexamethasone and low-dose olanzapine). The study enrolled 152 patients who received 484 cycles of chemotherapy. Forty patient cycles were classified as low risk (level 0) compared to 201, 162 and 81 that were classified as high-risk levels 1, 2 and 3, respectively. Complete control of acute and delayed vomiting was comparable and was achieved in over 85 % of patients across all risk levels (p = 0.56 and p = 0.99). In contrast, complete control of acute and delayed nausea was reduced in risk levels 1 to 3 compared to level 0 (acute = 51.2, 58.0, 45.7 vs. 70.0 %; p = 0.013)-(delayed = 32.8, 45.7, 34.6 vs. 62.5 %; p < 0.001). Despite the addition of aprepitant, extended-duration dexamethasone and olanzapine, patients at high risk for CINV due to personal risk factors failed to achieve good nausea control.

Palonosetron in the prevention of chemotherapy-induced nausea and vomiting: an evidence-based review of safety, efficacy, and place in therapy.

Introduction: The second-generation 5-hydroxytryptamine-3 (5-HT3) receptor antagonist palonosetron is effective in the prevention of chemotherapy-induced nausea and vomiting (CINV) associated with highly and moderately emetogenic chemotherapy (HEC and MEC, respectively). In addition, palonosetron has been the first and, at present, the only 5-HT3 receptor antagonist to have a specific indication for the prevention of delayed CINV associated with MEC. The unique pharmacology of this antagonist is thought to partly explain its improved efficacy against delayed symptoms.Aims: To review the evidence underlying the use of palonosetron in preventing CINV.Evidence review: A recent meta-analysis consistently showed that palonosetron significantly increases the control of both emesis and nausea during the acute and delayed phases after single-day HEC or MEC. Consistent with these findings from trials that did not include an neurokinin-1 (NK-1) receptor antagonist, randomized controlled trials recently showed that a triple combination with palonosetron achieves significantly better control of delayed CINV, particularly delayed nausea, in patients undergoing HEC or the high-risk combination of an anthracycline and cyclophosphamide (AC). Evidence from randomized studies also supports palonosetron as a valuable option to reduce the total corticosteroid dose administered in patients undergoing multiple cycles of MEC or AC chemotherapy. Additional benefits of palonosetron include the lack of a warning on cardiac safety and no known clinically significant drug–drug interactions.Place in therapy and conclusion: Evidence currently available indicates that palonosetron significantly adds to the clinician’s ability to effectively control CINV in patients undergoing HEC or MEC. It is recommended in the international guidelines for the prevention of CINV caused by MEC. The high safety profile and the opportunity to reduce the total corticosteroid dose with no loss in efficacy against delayed CINV should also contribute to a wider use of palonosetron in clinical practice.

Efficacy of antiemetic therapy in patients undergoing laparoscopic cholecystectomy

IntroductionA high incidence of postoperative nausea and vomiting has been observed in patients undergoing laparoscopic cholecystectomy (20–40%). This causes an increase in patient discomfort, a delay in recovery, and an increase in hospital stay. ObjectiveCompare the efficacy of ondansetron plus metoclopramide and ondansetron alone in the control of postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy. Material and methodsA comparative, prospective, experimental, longitudinal double blind study was performed with 30 patients programmed for laparoscopic cholecystectomy. The Apfel score was applied postoperatively. Patients were divided into two groups with 15 participants. Metoclopramide 10mg and ondansetron 4mg were administered in the first Group (A), and ondansetron 4mg in the second Group (B), after induction of anesthesia. Nausea and vomiting were evaluated for 24h postoperatively using a Likert scale. ResultsOf the patients who presented nausea, the condition was mild. The patient who presented vomiting, vomited only once. Neither group required rescue drugs. Regarding the Apfel score, there was no correlation between the percentage of stratified risk and the patients who presented postoperative nausea and vomiting. ConclusionsNo statistically significant difference was observed between ondansetron plus metoclopramide and ondansetron alone in patients subjected to laparoscopic cholecystectomy.

Defining optimal control of chemotherapy-induced nausea and vomiting-based on patients' experience.

A considerable challenge when comparing antiemetic trials for chemotherapy-induced nausea and vomiting (CINV) is the large number of outcome measures for nausea and vomiting. The objective of this study is to determine the optimal definition of CINV control from the patients' perspective. Patients with early-stage breast cancer who had received anthracycline-cyclophosphamide-based chemotherapy were surveyed. They were asked about their experiences of CINV and perceptions of different CINV assessment tools. Of 201 patients approached, 168 (83 %) completed the survey. Patients consistently ranked nausea over vomiting as the "worst side effect from chemotherapy." Despite the use of multi-agent antiemetic regimens, 71 % of patients experienced nausea and 26 % vomiting. Only 57 % of patients with any nausea or vomiting took rescue medications and only then when the symptom was severe. Most (76 %) patients believed that the primary end point of antiemetic trials should include the absence of both nausea and vomiting. Patients felt that CINV should be evaluated for the overall period post chemotherapy (i.e., days 1-5) and not simply the acute (the first 24 h) or delayed (days 2-5) periods. Patients strongly favored a CINV end point that includes the absence of both nausea and vomiting. Patients' experience with CINV is underestimated when nausea is not included in composite end points. "Use of rescue medication," a commonly used surrogate for emesis control, is inappropriate as it underestimates nausea. A standardized primary end point that includes nausea is essential if CINV control is to be improved.