Acute Chemotherapy-induced Nausea Research Articles

Effect of Inhaled Peppermint Aromatherapy on Chemotherapy-Induced Acute Nausea and Vomiting among Women with Breast Cancer in Gresik Regency

Background: Chemotherapy-induced acute nausea and vomiting are commonly experienced by breast cancer patients. Therefore, this study aimed to determine the effect of inhaled peppermint aromatherapy on chemotherapy-induced acute nausea and vomiting among women with breast cancer.Methods: This pre-experimental study was conducted using a one-group pre-post-test design approach. The sample included 28 women with breast cancer undergoing chemotherapy at the Chemotherapy Unit of Semen Gresik Hospital, Gresik, Indonesia. Respondents were administered 0.25 cc of peppermint essential oil on a cotton ball and then inhaled for 10 minutes. Data were collected using Rhodes Index Nausea Vomiting & Retching (RINVR) and analyzed with a paired sample t-test.Results: The pre-test showed that the majority of respondents experienced a moderate level of nausea and vomiting. After the intervention, the post-test results indicated mild nausea and vomiting. The statistical analysis showed that peppermint aromatherapy significantly affected chemotherapy-induced acute nausea and vomiting with a p-value of 0.001 (α<0.05).Conclusions: There was a significant improvement in chemotherapy-induced acute nausea and vomiting after the administration of peppermint aromatherapy. Therefore, this intervention could be used as a non-pharmacological complementary therapy to reduce chemotherapyrelated nausea among breast cancer patients

The effect of digital acupressure on chemotherapy-induced nausea in Indonesian patients with stages III-IV breast cancer

Patients with breast cancer are reported to experience nausea and vomiting during neoadjuvant chemotherapy. Both remain the most troubling side effects of chemotherapy, even in the era of new antiemetic agents. Hence, our study aims to investigate the clinical outcome of acupressure in the prevention of acute chemotherapy-induced nausea (CIN) by evaluating the frequency and severity of nausea. This study was a randomized controlled trial consisting of 42 breast cancer patients, divided equally into two groups (experimental (acupressure) and control groups). Digital acupressure was performed at pericardium 6 (P6 or Neiguan) and stomach 36 (ST36 or Zusanli) points. Assessment of nausea was conducted by examining the frequency of nausea and measuring nausea-related subscores from the simulator sickness questionnaire (SSQ) and visual analog scale (VAS) within one hour after chemotherapy. Our study indicated that patients in the experimental group had significantly lower frequency and less severe nausea than those in the control group. In conclusion, acupressure effectively decreased the frequency and severity of nausea in breast cancer patients undergoing neoadjuvant chemotherapy. Acupressure could be implemented as an adjunct intervention in addition to antiemetic therapy for the prevention of CIN in breast cancer patients.

Risk factors associated with nausea and vomiting in children with cancer receiving chemotherapy.

Despite treatment with antiemetic medications, nausea remains uncontrolled for many children receiving chemotherapy. One reason is that risk factors for nausea in children remain poorly explored. The purpose of this study was to identify risk factors for chemotherapy-induced nausea (CIN) in children. Prospective, observational study including 101 children (median age 6.4 years, range 0.8-17.9) with cancer receiving moderately or highly emetogenic chemotherapy. Primary endpoints were complete control of acute and delayed CIN, defined as no nausea in the acute phase 0-24 h after chemotherapy and in the delayed phase starting after the acute phase and ending 5 days later. Multivariable analyses included age, sex, cancer type, susceptibility to motion sickness, chemotherapy duration, numbers of antiemetics, co-administration with opioids or tricyclic antidepressants, and previously uncontrolled nausea or vomiting. Acute CIN was associated with susceptibility to motion sickness (odds ratio [OR] 5.73, 95% confidence interval [CI] 1.36-33.7) and older age (OR 4.19, 95% CI 1.30-14.7), comparing age group 8-18 years with 0-3 years. Delayed CIN was associated with uncontrolled acute nausea or vomiting (OR 10.3, 95% CI 2.65-50.9), highly emetogenic chemotherapy (OR 8.26, 95% CI 1.17-76.8), and having a hematologic cancer type (OR 7.81, 95% CI 1.05-79.2). Susceptibility to motion sickness and age can influence the risk of acute CIN. More research is needed on how best to integrate risk information in preventive antiemetic strategies. Sufficient acute nausea and vomiting control are crucial to prevent delayed CIN.

Does a single dose of palonosetron have any role in preventing acute chemotherapy-induced nausea and vomiting in pediatric osteosarcoma patients without dexamethasone? A randomized clinical trial.

Chemotherapy-induced nausea and vomiting (CINV) is a troublesome side-effect of chemotherapy in pediatric patients undergoing osteosarcoma treatment. In this context, the role of 5-hydroxytryptamine-3 (5-HT3) receptor antagonists needs to be explored. To evaluate the superiority of single-dose palonosetron over granisetron in pediatric patients undergoing highly emetogenic chemotherapy (HEC) for osteosarcoma. In this double-blind, randomized study, pediatric patients were assessed in terms of acute nausea and vomiting following HEC for osteosarcoma. These children were assigned to group 1 (palonosetron) and group 2 (granisetron) without any other antiemetic prophylaxis. The primary outcome variable was the children's segment with a complete response (CR) during the acute phase of the 1st on-study chemotherapy cycle. The risk factors associated with the emesis were analyzed. The patients were followed up for the first 24 h after chemotherapy. A total number of 200 children were evaluated in terms of the response, and other factors that might alter the response were assessed in the 2 groups. These 200 children underwent 604 blocks of chemotherapy. Complete responses were documented in 83% and 72% of children receiving palonosetron and granisetron, respectively, during the acute phase. Only dexamethasone, used as a rescue medication, was found to be a significant risk factor that predisposed to the response (p < 0.05). Single-dose palonosetron is an effective alternative to granisetron for preventing CINV in children receiving HEC for osteosarcoma.

The Role of Clinical Guidelines for the Management of Chemotherapy-Induced Nausea and Vomiting in Children with Cancer

Background: Nausea and vomiting are among the most important side-effects associated with chemotherapy in children with cancer, affecting the quality of their lives. Clinical guidelines for selecting antiemetics are effective in reducing acute chemotherapy-induced nausea and vomiting (CINV).&#x0D; Materials and Methods: The present quasi-experimental study compared the effectiveness of the Pediatric Oncology Group of Ontario (POGO) CINV guideline with that of conventional arbitrary therapies for CINV in 82 children aged 6 months to 16 years old. Out of 177 cycles of chemotherapy, in 101 cycles patients were treated according to POGO-CINV Guideline; in the other 76 cycles, patients were treated with arbitrary types and doses of antiemetics. Then, vomiting in the first 24 hours after chemotherapy in both groups was measured and compared.&#x0D; Results: In this study, 82 patients hospitalized in the Hematology Department of Dr. Sheikh Children’s Hospital were enrolled, of whom 48 patients (58.7%) were boys and 34 (41.3%) were girls. The mean age of patients was 6.24±4.47 years (6 months to 16 years). The results of the current study showed that using a protocol for the prevention of vomiting based on the patient’s age and the type of chemotherapy is superior to conventional management of CINV. Findings showed that the frequency of nausea and vomiting in the protocol group was significantly reduced in comparison with the control group (p˂0.005). Moreover, a reduction in the frequency of nausea and vomiting was quite significant in the sub-categories of the protocol group who had received high-risk or moderate-risk emetogenic drugs (p˂0.005).&#x0D; Conclusion: The results of the current study showed that using the POGO guideline, which takes into account the patient’s age and the type of chemotherapy, is more effective than arbitrary management of CINV, particularly in children.

Effects of immersive virtual reality for preventing and managing anxiety, nausea and vomiting among paediatric cancer patients receiving their first chemotherapy: A study protocol for an exploratory trial.

BackgroundAnxiety, nausea and vomiting are common side effects suffered by paediatric patients receiving chemotherapy. Emerging evidence supports the efficacy of immersive virtual reality (IVR) on improving anxiety and distress symptoms including nausea and vomiting among this vulnerable group. This trial aims to assess the feasibility and acceptability of IVR for preventing and managing anxiety, nausea and vomiting among paediatric cancer patients receiving their first chemotherapy.Method and analysisAn exploratory trial supplemented by qualitative methods will be conducted. We will recruit 20 paediatric patients who are aged between 6 and 12 years, chemotherapy naïve, scheduled to receive their first intravenous chemotherapy and able to understand Chinese. Participants will be randomly allocated to intervention or control groups. The intervention group will receive the IVR intervention for three sessions as follows: 4 hours before chemotherapy, 5 minutes before and during their first course chemotherapy and 5 minutes before and during their second course chemotherapy. The control group will receive standard care only. Main outcome measures included (1) key parameters for the design of a definitive trial (i.e. screening, eligibility, consent and withdrawal rates); (2) anxiety, anticipatory and acute chemotherapy-induced nausea and vomiting for collection of preliminary data; (3) feasibility and acceptability of the intervention. Semi-structured interviews will be conducted with patients, parents and oncology nurses. Generalized estimating equations model will be used to compare each of the outcome measures across the time points between the two groups. Qualitative data will be analysed by conventional content analysis.Expected resultsThe results of this exploratory trial will inform the design and conduct of future definitive trial.Trial registration number ChiCTR1900021694; Pre-results.

Abstract 593: Ocular drops of palonosetron reduce chemotherapy-induced acute nausea and vomiting in the dog

Abstract Background: Nausea and vomiting are common side effects of cancer therapies thereby seriously affecting the quality of life of patients. Therefore, the prevention or treatment of chemotherapy-induced nausea and vomiting has become an important part of the comprehensive treatment of cancer. Several 5-HT3 receptor antagonists have been developed in the treatment of nausea and vomiting using mainly the oral route of administration (which is not convenient due to vomiting) or the intravenous route. In this study we tested whether ocular administration of the 5-HT3 receptor antagonist palonosetron (eye drops) could prevent nausea and vomiting associated with intravenous cisplatin injection in dogs. Methods: Six adult male Beagle dogs (10-13 kg) were included in a randomized crossover study. This study was carried out in AAALAC facilities in strict accordance with the European and French animal welfare regulations for animal use in experimentation. Dogs were administered 18 mg/m2 cisplatin intravenously over a 20-min period, followed 45 min later by ocular administration (eye drops, 200µL/eye) of either placebo (2% povidone in saline) or palonosetron (30 or 120 µg/kg). The number of vomits and nausea associated behaviours, scored on a visual analogue scale (VAS), were recorded every 15 min for 7 h following cisplatin administration. Blood samples were collected to measure plasma levels of palonosetron. Results: The placebo treated group vomited an average number of 10.2±2.1 times (range 5-17) over the 7-h period following cisplatin infusion. Ocular administration of palonosetron at 30 μg/kg in cisplatin-treated dogs very strongly and significantly decreased vomiting episodes, with only 1 vomiting episode in 2 dogs overall (p&amp;lt;0.0001). After ocular administration of palonosetron at 120 μg/kg, no vomiting episodes were observed in any dog throughout the observation period (p&amp;lt;0.0001). With regards to the VAS, in the placebo-treated group the nausea-associated behaviour started between 2.5 and 2.75 h after the end of the cisplatin infusion and peaked between 3.75 and 4.25 h after the end of the cisplatin infusion. The area under the curve (AUC) of VAS was 7344 ± 1050 mm*min in the placebo-treated group. Ocular administration of palonosetron at 30 or 120 µg/kg in cisplatin-treated dogs decreased the VAS score strongly. The VAS AUCs were 320 ± 268 (p&amp;lt;0.0001) and 0 ± 0 mm*m (p&amp;lt;0.0001) in 30 µg/kg and 120 µg/kg palonosetron groups, respectively. Plasma palonosetron concentration reached 10.3 ± 3.9 ng/mL, 5 min after ocular administration of palonosetron at 30 µg/kg and 2.8 ± 0.5 ng/mL and 0.9 ± 0.2 ng/mL at 2 h and 6 h post dosing, respectively. Conclusions: This study demonstrates for the first time that palonosetron administered via ocular route produces a rapid clear-cut anti-emetic and anti-nausea effect in conscious dogs exposed to cisplatin. This finding points out the tremendous interest of this novel and convenient route of administration which could help improving the quality of life of patients. Citation Format: Sandra Nourry, Minja Hyttila-Hopponen, Pierre Montagne, Lasse Saloranta, Sari Pappinen, Jouko Levijoki, Christophe Drieu La Rochelle. Ocular drops of palonosetron reduce chemotherapy-induced acute nausea and vomiting in the dog [abstract]. In: Proceedings of the Annual Meeting of the American Association for Cancer Research 2020; 2020 Apr 27-28 and Jun 22-24. Philadelphia (PA): AACR; Cancer Res 2020;80(16 Suppl):Abstract nr 593.

Guideline concordant care for prevention of acute chemotherapy-induced nausea and vomiting in children, adolescents, and young adults.

Prescribing guideline-recommended anti-emetics is an effective strategy to prevent CINV. However, the rate of guideline-concordant care is not well-understood. The purpose of this study was to describe the proportion of pediatric, adolescent, and young adult patients receiving HEC or MEC who received guideline-concordant antiemetic prophylaxis for acute CINV and to identify potential predictors of guideline-concordant antiemetic prophylaxis. Using electronic health record data from 2016 through 2018, a retrospective single-institution cohort study was conducted to investigate how often patients less than 26years of age receiving moderately or highly emetogenic chemotherapy receive guideline-concordant prophylaxis for acute CINV. Guideline-concordant care was defined according to guidelines from the Pediatric Oncology Group of Ontario for patients < 18years and the American Society of Clinical Oncology for those ≥ 18years. Independent variables included: sex, age, insurance status, race, ethnicity, cancer type, chemotherapy regimen, clinical setting, chemotherapy emetogenicity, and patient location. Predictors of receiving guideline-concordant care were determined using multiple logistic regression. Of 180 eligible patients, 65 (36.1%) received guideline-concordant care. In multivariable analysis, being treated in adult oncology setting (aOR 14.3, CI95 5.3-38.6), with a cisplatin-based regimen (aOR 3.5, CI951.4-9.0), solid tumor diagnosis (aOR 2.2, CI95 1.0-4.8), and commercial insurance (aOR 2.4, CI95 1.1-5.2) were associated with significantly higher likelihood of receiving guideline-concordant care. Multi-level factors were associated with receiving guideline concordant care for prevention of CINV in children, adolescents, and young adults receiving emetogenic chemotherapy. These findings can inform current efforts to optimize implementation strategies for supportive care guidelines.

Adherence to clinical practice guidelines for the prevention of acute chemotherapy-induced nausea and vomiting in children, adolescents, and young adults with cancer receiving their first cycle of highly emetogenic chemotherapy.

19 Background: Prescribing guideline-recommended anti-emetics for the prevention of chemotherapy-induced nausea and vomiting (CINV) is an effective strategy to prevent a common treatment-related adverse effect in children, adolescents and young adults (AYAs) with cancer that impacts quality of life. The rate of guideline-concordant care (GCC) is not well-understood. Methods: Using electronic health record data Columbia University Irving Medical Center from a 3-year period, we conducted a retrospective single-institution cohort study to investigate how often children and AYAs (age 26 or less) receive GCC to prevent CINV prior to the first administration of highly-emetogenic chemotherapy. We defined GCC from the Pediatric Oncology Group of Ontario guideline for patients &lt; 18 years and the American Society of Clinical Oncology guideline for those ≥ 18 years. Independent variables included: sex, age, insurance status, race, ethnicity, cancer type, chemotherapy regimen, clinical setting (adult or pediatric oncology), and patient location (inpatient or outpatient). Predictors of GCC were determined using multiple logistic regression. Results: Of 91 included patients, 39 (43%) received GCC. Those treated in adult oncology setting (OR 7.5, 95% CI: 2.7–20.7), receiving cisplatin-based chemotherapy (OR 3.5, CI: 1.4–8.5), or with commercial insurance (OR 2.7, CI: 1.1–6.3) were more likely to receive GCC. In multivariable analysis, patients treated in adult oncology had 6.4 higher odds (CI: 2.1–19.1, p&lt;.001) and those receiving cisplatin 4.6 higher odds (1.6–13, p&lt;.01) of GCC. Conclusions: Clinical setting and chemotherapy regimen independently predicted GCC for prevention of CINV in children and AYAs receiving highly-emetogenic chemotherapy. These findings can inform current efforts to optimize implementation strategies for supportive care guidelines by focusing on specific provider- and patient-level factors.

Adherence to pediatric acute chemotherapy-induced nausea and vomiting guidelines in Canadian hospitals.

Chemotherapy-induced nausea and vomiting (CINV) impacts quality of life for patients. Guidelines for emetogenicity classification and prevention of CINV in children were recently published and endorsed by pediatric oncology organizations. A multicenter chart review was performed at four Canadian pediatric oncology centers examining rates of prescribing adherence to CINV guidelines between January 2012 and December 2015. Eligible patients received their first chemotherapy course of highly emetogenic chemotherapy (HEC) or moderately emetogenic chemotherapy (MEC). Guideline adherence was described in 204 patients as antiemetic-only guideline adherence (AGA; examined medication/class prescribed only) and complete guideline adherence (CGA; examined medication/class, dose, frequency, and duration prescribed). Adherence was 29% (HEC 30%, MEC 19%, P=0.1) and 2% for AGA and CGA patients, respectively. Vomiting in the first 24h was experienced by 24% of AGA and 34% of non-AGA patients (P=0.13), with mean breakthrough medication doses similar between AGA and non-AGA groups (HEC 1.8 vs 1.5, P=0.45; MEC 3 vs 1.42, P=0.35). In the first 24h, HEC AGA patients achieved a complete control rate of 37% vs 45% for non-AGA patients (P=0.31), while patients receiving AGA therapy for MEC achieved a complete control rate of 80% vs 24% for non-AGA patients (P=0.02). Adherence to guidelines was low across all four pediatric institutions. Each center used different approaches to implement pediatric CINV guidelines. Complete CINV control was low, with reports of emesis high, indicating that patients are not receiving optimal treatment.

Acute chemotherapy-induced nausea and vomiting in children with cancer: Still waiting for a common consensus on treatment.

Chemotherapy-induced nausea and vomiting (CINV) is one of the most common treatment side-effects, and remains a significant concern, in children undergoing chemotherapy. Although adult patients receive chemotherapy regimens combined with appropriate standardized antiemetic treatment, children can receive markedly varying antiemetic treatments. A narrative review of CINV was performed regarding CINV definition, scoring system, prevention and treatment, specifically focussing on studies conducted with paediatric oncology patients. The review highlighted a lack of rigorously developed CINV scoring systems and standardized CINV pharmacological treatment for paediatric oncology patients. Different scoring systems were found to identify potential risk factors for CINV associated with the use of several different antiemetic drugs, however, few studies have been performed in children undergoing chemotherapy. Thus, CINV remains a distressing and partially controlled side-effect in the paediatric patient population. To reduce emesis and improve quality of life in paediatric oncology patients, standardized antiemetic treatment may be preferred, using a unique CINV scoring system that accounts for the emetogenic level of the chemotherapy regimen adopted and the children’s clinical characteristics.

Evaluating the antiemetic administration consistency to prevent chemotherapy-induced nausea and vomiting with the standard guidelines: a prospective observational study.

Nausea and vomiting (NV) are the most prevalent adverse effects of chemotherapy (CT). This study was conducted to evaluate adherence of the health care team to standard guidelines for antiemetics usage to prevent acute chemotherapy-induced nausea and vomiting (CINV) in a large CT center. A prospective study was performed during an 11-month period on patients receiving CT. A form was designed to collect patients’ demographic information and their chemotherapeutic and antiemetic regimen data. The Likert scale was used to measure the effectiveness of the antiemetics in patients. In this study, the effect of patient-related risk factors on the incidence rate of CINV was examined. Based on the results, CINV events were reported by 74.4% of patients. The antiemetic regimen of 71.2% of the patients complied with the guidelines. The complete response, complete protection, and complete control end points did not differ significantly between patients undergoing guidelines-consistent prophylaxis or guidelines-inconsistent prophylaxis. The females clearly showed a higher incidence rate of CINV (P=0.001) during the first course of CT (P=0.006). A history of motion sickness did not affect the incidence of NV. The maximum compliance error occurred for the use of aprepitant, as 16.16% of the patients who were receiving aprepitant did not comply with its instructions. The results of this study highlight how CINV was controlled in this center, which was significantly lower than that of the global standard. Perhaps, factors such as noncompliance to antiemetic regimens with standard guidelines and the failure to adhere to the administration instructions of the antiemetics were involved in the incomplete control of CINV.

Guideline for the prevention of acute chemotherapy-induced nausea and vomiting in pediatric cancer patients: A focused update.

This update of the 2013 clinical practice guideline provides clinicians with guidance regarding the use of aprepitant and palonosetron for the prevention of acute chemotherapy-induced nausea and vomiting (CINV) in children. The recommendations were based on three systematic reviews. Substantive changes were made to the guideline recommendations including the inclusion of palonosetron to the 5-HT3 antagonists recommended for children receiving highly emetogenic chemotherapy (HEC) and the recommendation of aprepitant for children 6 months of age or older receiving HEC. To optimize CINV control in children, future work must focus on closing critical research gaps.

2016 updated MASCC/ESMO consensus recommendations: Prevention of acute chemotherapy-induced nausea and vomiting in children.

To update the 2009 recommendations for the prevention of acute chemotherapy-induced emesis in children. We updated the original systematic literature search. Randomized studies were included in the evidence to support this guideline if they were primary studies fully published in full text in English or French; included only children less than 18years old or, for mixed studies of adults and children, reported the pediatric results separately or the median or mean age was no more than 13years; evaluated acute chemotherapy-induced nausea and vomiting (CINV) prophylaxis; provided sufficient information to permit determination of the emetogenicity of the antineoplastic therapy administered or the study investigators stated the emetogenicity of the chemotherapy administered; included an implicit or explicit definition of complete acute CINV response; described the antiemetic regimen in full; and reported the complete acute CINV response rate as a proportion. Twenty-five randomized studies, including eight published since 2009, met the criteria for inclusion in this systematic review. Prophylaxis with a 5-HT3 antagonist (granisetron or ondansetron or palonosetron or tropisetron)±dexamethasone±aprepitant is recommended for children receiving highly or moderately emetogenic chemotherapy. For children receiving chemotherapy of low emetogenicity, a 5-HT3 antagonist is recommended. The findings of several randomized trials were used to update recommendations for the prevention of acute CINV. However, significant research gaps remain and must be addressed before CINV control in children can be optimized.

Chemotherapy-Induced Nausea and Vomiting Prophylaxis: Practice Within the Children's Oncology Group

The Children's Oncology Group (COG) has endorsed a clinical practice guideline (CPG) for acute chemotherapy-induced nausea and vomiting (CINV) prophylaxis in children with cancer. This project aims to describe current acute CINV prophylaxis practice at COG sites and the gap between this practice and CPG recommendations. Two surveys were developed. The first survey, sent to 94 cancer control and supportive care responsible individuals (CCL RIs) at 94 COG institutions, asked if the institution had a standardized approach to practice and focused on antiemetic agent choice. The second survey, sent to 54 pharmacists at COG sites where the CCL RI indicated that there was a standardized approach to CINV prophylaxis practice, focused on antiemetic dosing. Survey results were described and analyzed for consistency with the CPG recommendations. Among the 69 respondents to the first survey, 54 (78%) stated that their institutions have a standardized approach to CINV prophylaxis practice. However, antiemetic choice varied widely among respondents. Results from the 36 respondents to the second survey also demonstrated significant antiemetic dosing practice variability. Frequent sources of deviation from CPG recommendations were as follows: antiemetic choice when corticosteroids are contraindicated, dexamethasone dosing, aprepitant use in children less than 12 years, and aprepitant use in the presence of a known or suspected drug interaction. There is a great diversity in the CINV prophylaxis provided to children with cancer at COG sites. Concerted strategies are required to improve awareness of the current CINV prophylaxis CPG and to facilitate CPG-consistent CINV prophylaxis.

Optimization of Melt in Mouth Tablets of Palonosetron HCl using 32 Full Factorial Design

Palonosetron HCl is a 5HT3 antagonist licensed for the prevention of acute chemotherapy-induced nausea and vomiting (CINV) associated with highly emetogenic chemotherapy agents (HEC) and the prevention of CINV associated with moderately emetogenic cancer chemotherapy (MEC). It has a substantially longer half-life (Approximately 40 h). So, it was plan to prepare melt in mouth tablet which could rapidly dissolved and absorbed which may produce rapid onset of action. Melt in mouth tablets were prepared by direct compression method using various superdisintegrants like Kyron T314 and Vivasol, and evaluated for pre compression and post compression parameters. A 32 full factorial design was applied systematically to optimize responses. The concentration of Kyron T314 (X1) and concentration of Vivasol (X2) were selected as independent variables and disintegration time (Y1) and wetting time (Y2) as dependent variables. The prepared tablets were evaluated for hardness, friability, disintegration time, wetting time, drug content and in vitro drug release. The results indicated that concentration of (X1) and (X2) significantly affected (Y1) and (Y2). Regression analysis and numerical optimization were performed to identify the best formulation. Similarity (f2) and dissimilarity (f1) study for optimization batch was also carried out. Batch P9 was found to be best batch with 10.43 s. disintegration time, 19.53 s. wetting time and 99.02% drug release in 30 min. There was no drastic change in the result of tablets of optimized batch at end of six month accelerated stability study.

An investigation of the effects of therapeutic touch plan on acute chemotherapy-induced nausea in women with breast cancer in Isfahan, Iran, 2012-2013.

Introduction:Nausea is the worst and most prevalent chemotherapy-induced complication experienced by 70–80% of patients despite mediation therapy. Reduction of nausea is one of the most important roles of oncologist nurses. Today, complementary therapies in addition to classic medicine, because of their lower costs, receive much attention. Nonetheless, their safety and effectiveness are not yet proven. The purpose of this research was to investigate the effect of therapeutic touch plan as a complementary therapy on acute nausea in women with breast cancer in 2012–2013 in Isfahan, Iran.Materials and Methods:A quasi-experimental, single-blind, randomized control trial with three groups (control, placebo and intervention) was performed at the Isfahan Seyedolshohada (AS) Teaching Hospital, Isfahan, in 2012–2013. The intervention was therapeutic touch plan on women with breast cancer, with the three groups receiving the same medicine regimen. Information was recorded by a checklist after infusion of chemotherapy drugs. Data analysis was performed by SPSS, ANOVA and Kruskal–Wallis tests.Results:The ANOVA test showed that the therapeutic touch plan was significantly effective in reducing the duration of nausea compared with the control and placebo groups (P < 0.001). The Kruskal–Wallis test showed that the frequency of occurrence of nausea was also reduced in the intervention and placebo groups compared with the control group (P < 0.001). The therapeutic touch plan was significantly effective in delaying the onset of nausea compared with the control and placebo groups (P < 0.001).Conclusion:This research showed that the therapeutic touch plan is effective in reducing acute chemotherapy-induced nausea; thus, education and implementation of the therapeutic touch plan is proposed for clinical nurses.

PWSC2-4 - Randomized Controlled Study Comparing Two Doses of Intravenous Granisetron Chemotherapy-Induced Nausea and Vomiting

Objective: The aim of this study was to assess the non-inferiority of 1 mg to 3 mg granisetron injection for the treatment of acute chemotherapy-induced nausea and vomiting and to evaluate the tolerability of granisetron given at 1 mg in Japanese cancer patients.Methods: Patients with cancer receiving highly emetogenic chemotherapy were enrolled in this single-blind randomized controlled study. Patients were randomly assigned to receive granisetron at a single dose of 1 mg or 3 mg. The primary endpoint was the rate of complete protection from emetic events(no vomiting, no retching, and no need for rescue medication)during the first 24 hours following the initiation of chemotherapy.Results: There were 89 patients in the 1-mg group and 90 patients in the 3-mg group. Complete protection was achieved in 70 patients(78.7%) in the 1-mg group and 73(81.1%) patients in the 3-mg group. The one-sided test did not reveal non-inferiority of either dose of granisetron to the other at a 5.0% significance level.Conclusion: Our data failed to show the non-inferiority of 1 mg to 3 mg of granisetron administered as a single dose. However, the rate of complete protection from nausea and vomiting was similar in the two groups. Given the recommended dosage in the guidelines and the economic need for reduction of medical care expenses in Japan, prophylactic administration of granisetron at 1 mg may be an appropriate treatment alternative for acute chemotherapy-induced nausea and vomiting in cancer patients.

Evidence to support use of palonosetron over generic serotonin type 3–receptor antagonists for chemotherapy-induced nausea and vomiting

Palonosetron, a serotonin type 3–receptor (5-HT3) antagonist, was approved by the Food and Drug Administration (FDA) in 2003 for the prevention of acute chemotherapy-induced nausea and vomiting (CINV) associated with initial and repeat courses of highly emetogenic chemotherapy (HEC) and moderately

Does Pharmacogenomics Account for Variability in Control of Acute Chemotherapy-Induced Nausea and Vomiting with 5-Hydroxytryptamine Type 3 Receptor Antagonists?

Chemotherapy-induced nausea and vomiting is one of the most concerning adverse drug effects from cytotoxic chemotherapy. Despite appropriate use of antiemetic guidelines, 20-30 % of patients experience breakthrough nausea and vomiting secondary to chemotherapy. To assess the variability of 5-hydroxytryptamine type 3 receptor antagonist efficacy caused by genetic variation, a review of the available literature was conducted. From the literature, three sources of pharmacogenomic variability were identified: polymorphisms associated with 5-hydroxytryptamine type 3 receptor subunits, drug metabolism via cytochromes P450, and drug transport in the body. Testing for receptor subunit polymorphisms is not applicable to a clinical setting at this time; however, cytochrome P450 2D6 testing is FDA-approved and widely accessible. Cytochrome P450 2D6 ultrarapid metabolizers and poor metabolizers displayed altered antiemetic efficacy when compared with intermediate metabolizers and extensive metabolizers. We postulate that testing for cytochrome P450 2D6 phenotypes may be the most accessible way to provide individualized antiemetic therapy in the future.