Functional Assessment Of Anorexia/Cachexia Therapy Research Articles

#2900 Appetite changes as a predictor of mortality among end-stage renal disease patients (ESRD) on maintenance hemodialysis: one year survival analysis

Abstract Background and Aims End-stage renal disease (ESRD) has become a major health problem worldwide. Appetite loss is a dominant feature of the disease which plays an important role in protein energy wasting and malnutrition, with subsequent higher rates of mortality. The study aimed to examine appetite changes among patients with ESRD on maintenance hemodialysis and its association with one-year mortality. Method This is a prospective observational study that was conducted at Mansoura Nephrology and Dialysis Unit (MNDU), Mansoura University and Aga Hospital Dialysis Unit over a period of one-year Patients who fulfilled inclusion and exclusion criteria were included. The study was explained to all participants and informed consent was obtained. All demographic, clinical, and laboratory data were collected. Appetite was assessed using the following 4 scores: subjective assessment of appetite, the self-assessment of appetite changes for 30 days, The Visual Analog Scale (VAS), and The Functional Assessment of Anorexia/Cachexia Therapy (FAACT). All patients were followed up for one year to report the mortality events. Results The current study included 162 hemodialysis patients whose age (SD) was 48.72±12.64 years, and males constituted 57.4% of them. Around 44.4% of the cases reported having good appetite using the subjective assessment score, and 13% reported decreased appetite using the self-assessment of appetite score. The median VAS score was 80, and the FAACT score ranged from 7 to 32 with a mean value of 15.85. After one year of observation, death occurred in 24/162 (14.8%). There were statistically significant differences in mean values of three appetite scores among both dead and alive groups with lower values reported in the deceased one [self-assessment of appetite (p=0.019), VAS score (p=0.001), and FACCT (p=<0.001)]. The ROC analysis shows that FACCT & VAS scores were able to determine patients who destinated to mortality with area under curve (AUC) of (0.774 &0.704), at a cut-off point of (14.5%, and 75), with sensitivity of (83.3% &and 66.7%) and specificity of (61.6%, and 53.6%), respectively. Kaplan Meier survival analysis demonstrated that VAS & FACCT scores had a statistically significant effect on median survival time among studied cases. Lower median survival time was detected among cases with decreased appetite by self-assessment tool, VAS score less than 80, and FACCT score less than 15. Kaplan-Meier and hazard curves for the included sample showed lower Median survival time (95% CI) among patients with diminished appetite by the 4 scores: 311.67(265.98-357.36) by self-assessment score (p=0.008), 344.28 (329.57-358.9) days by subjective assessment of appetite (p=0.28), 342.33(330.46-354.19) days by VAS score (p=0.016), and 332.01(314.6-349.43) days by FAACT score (p<0.0001). Cox regression analysis demonstrated that VAS and FACCT scores were statistically significant predictors of median survival time among studied cases (p<0.001, <0.001) and hazard ratio (HR) of (0.968 & 0.734), respectively. Conclusion Diminished appetite is prevalent among hemodialysis patients. Poor appetite is associated with higher mortality. Lower appetite score values can predict mortality among such patients.

Instruments for Evaluating the Nutritional Status of Cancer Patients Undergoing Antineoplastic Treatment: A Scoping Review

The use of validated tools to evaluate the nutritional status of the cancer patient provides guaranteed precision and reliability in their nutritional evaluation, ensuring that the information is accurate and reflects the patient's situation. The aim of this study was to identify the valid and reliable instruments in the evaluation of the nutritional status of cancer patients with a diagnosis of solid tumor undergoing antineoplastic treatment (chemotherapy and/or immunotherapy). A scoping review was conducted to search for original articles published in scientific journals in English, Spanish, or Portuguese in the past five years. In order to identify potentially relevant documents, searches were performed in the following databases: SCOPUS, WOS, CINAHL, MEDLINE, BVS, and PUBMED. DECS-MeSH descriptors and Boolean operators were used. In addition, the Arksey and O’Malley protocol, the Joanne Briggs Institute (JBI) method, and the flow chart of the Preferred Information Elements for Systematic Reviews and Meta-Analyses, known as PRISMA, were followed. The initial search strategy identified a total of 164 references, which were examined successively, leaving a final selection of ten studies. It was found that the most used instrument for nutritional evaluation was the Patient-Generated Subjective Global Assessment (PG-SGA). Other questionnaires also stood out such as the Mini Nutritional Assessment (MNA), the Malnutrition Universal Screening Tool (MUST), the Nutritional Risk Screening (NRS 2002), and the Functional Assessment of Anorexia/Cachexia Therapy (FAACT). The variation in the tools used ranges from subjective assessments to objective measurements, thus underlining the need for a comprehensive and individualized approach.

Cancer anorexia-cachexia syndrome is characterized by more than one inflammatory pathway.

The interdependence of cytokines and appetite-modifying hormones implicated in cancer anorexia-cachexia syndrome (CACS) remains unclear. This study aimed to regroup these cytokines and hormones into distinct inflammatory (or non-inflammatory) pathways and determine whether these pathways can classify patients with CACS phenotypes. Clinical characteristics of 133 patients [61.7% male; mean age=63.4 (SD: 13.1) years] with advanced cancer prior to oncology treatments were documented, including weight loss history. Patients completed the Functional Assessment of Anorexia-Cachexia Therapy (FAACT) questionnaire and Timed Up and Go test and had their sex-standardized skeletal muscle index(z-SMI) and fat mass index (z-FMI) derived using computed tomography scans. Their plasma levels of cytokines and appetite-modifying hormones were also determined. Date of death was recorded. Exploratory factor analysis (EFA) was used to regroup 15 cytokines and hormone into distinct inflammatory pathways (factors). For each patient, regression factor scores (RFS), which tell how strongly the patient associates with each factor, were derived. Two-step cluster analysis on the RFS was used to classify patients into groups. CACS phenotypes were correlated with RFS and compared between groups. Groups' survival was estimated using Kaplan-Meier analysis. Patients had low z-SMI (mean=-3.78cm2 /m2 ; SD: 8.88) and z-FMI (mean=0.08kg2 /m2 ; SD: 56.25), and 62 (46.6%) had cachexia. EFA identified three factors: (F-1) IFN-γ, IL-1β, Il-4, IL-6, IL-10, IL-12, TGFβ1 (positive contribution), and IL-18 (negative); (F-2) IL-8, IL-18, MCP-1, TGFβ1, TNF-α (positive), and ghrelin (negative); and (F-3) TRAIL and leptin (positive), and TGFβ1 and adiponectin (negative). RFS-1 was associated with cachexia (P=0.002); RFS-2, with higher CRP (P<0.0001) and decreased physical function (P=0.01); and RFS-3 with better appetite (P=0.04), lower CRP (P=0.002), higher z-SMI (P = 0.04) and z-FMI (P < 0.0001), and less cachexia characteristics (all P<0.001). Four patient groups were identified with specific RFS clusters aligning with the CACS continuum from no cachexia to pre-cachexia, cachexia, and terminal cachexia. Compared to the other two groups, groups 1 and 2 had higher plasma levels of IL-18 and TRAIL. Group 1 also had lower inflammatory cytokines, adiponectin, and CRP compared to the other three groups. Group 3 had inflammatory cytokine levels similar to group 2, except for TNF-α and leptin which were lower. Group 4 had very high inflammatory cytokines, adiponectin, and CRP compared to the other 3 groups (all P<0.0001). Groups 3 and 4 had worse cachexia characteristics (P<0.05) and shorter survival (log rank: P=0.0009) than the other two groups. This exploratory study identified three distinct pathways of inflammation, or lack thereof, characterizing different CACS phenotypes.

Bojungikgi-tang for Anorexia in Lung Cancer Patients with Treated with Chemotherapy: A Single-arm, Open-label, Single-center Trial

Objectives: This study was to evaluate the effectiveness and safety of Bojungikgi-tang for lung cancer patients with anorexia.Methods: This was a single-arm, open-label, and single-center trial, and suitable participants took Bojungikgi-tang (Buzhongyiqi-tang in Chinese, Hochuekki-to in Japanese) three times a day before or between meals for six weeks (42 days). After registration of clinical trials (visit 2), they visited the hospital every three weeks (visits 3 and 4) and measured or tested the effectiveness or safety evaluation variables to analyze the results. The primary outcome was the anorexia/cachexia subscale (A/CS) of functional assessment of anorexia/cachexia therapy (FAACT) score.Results: Seventeen lung cancer patients were included in the intention-to-treat (ITT) analysis. Lung cancer patients had higher A/CS of FAACT scores after six weeks of Bojungikgi-tang administration compared to that at the baseline. This was not significant four lung cancer (p=0.1668). In the secondary outcomes, the visual analog scale (VAS) score of anorexia decreased significantly (p=0.0009), and the CD4/CD8 ratio (p=0.0396) and CD4 levels (p=0.0345) significantly increased after six weeks of treatment. No serious adverse events were reported with Bojungikgi-tang in lung cancer patients.Conclusions: Bojungikgi-tang can be an effective and safe treatment for anorexia in lung cancer patients undergoing chemotherapy.

Abstract CT108: First-in-patient study of the GDF-15 inhibitor ponsegromab in patients with cancer and cachexia: Safety, tolerability, and exploratory measures of efficacy

Abstract Background: Cachexia is common in patients with advanced cancer and has been associated with elevated serum growth/differentiation factor 15 (GDF-15) concentrations. This first-in-patient, phase 1b, study assessed the use of ponsegromab, a monoclonal antibody against GDF-15, in participants with advanced cancer and cachexia. Methods: Adult participants (n = 10) with cachexia, advanced cancer (non-small cell lung, colorectal, or pancreatic), and elevated serum concentrations of GDF-15 received open-label subcutaneous ponsegromab every three weeks (Q3W) for 12 weeks in addition to standard of care anti-cancer treatment. Study endpoints included assessment of ponsegromab safety, tolerability, and pharmacokinetics. Serum GDF-15 concentrations and exploratory measures of efficacy were also assessed. Results: No treatment-related adverse events or injection site reactions were reported. No adverse trends in clinical laboratory tests, vital signs, or electrocardiogram parameters attributable to ponsegromab dosing were evident. Ninety-two adverse events deemed unrelated to treatment were reported; most were mild (Grade 1 = 58.7%) or moderate (Grade 2 = 28.3%) in severity. All participants were negative for anti-drug antibodies at baseline (n = 10) and after receiving 5 doses (Q3W) of ponsegromab (n = 9). Mean unbound ponsegromab Ctrough ranged from 4.041-4383 ng/mL between Days 22-106. An elevated GDF-15 concentration was required for inclusion in the study. Following initiation of study treatment, median unbound GDF-15 concentration was reduced to below the lower limit of quantification (0.0424 ng/mL) on day 1 and remained suppressed until week 15 (3 weeks after final dose). Increases in body weight were observed at all time points during the treatment (weeks 3, 6, 9, and 12) and follow-up (weeks 15, 18, and 24) periods. The mean (SD) body weight at baseline was 70.49 (16.97) kg. An LS mean (SE) increase of 4.63 kg (1.98) was observed at week 12 (end of treatment); representing an increase of approximately 6.5% relative to baseline. Improvements in actigraphy-based assessments of physical activity and in quality of life, including appetite, as assessed by Functional Assessment of Anorexia-Cachexia Therapy (FAACT) total and subscale scores, were also observed during the course of ponsegromab treatment. Conclusions: In participants with advanced cancer, cachexia, and elevated baseline GDF-15, ponsegromab was well tolerated and suppressed serum GDF-15 concentrations to below the median concentration seen in healthy subjects. Preliminary evidence of efficacy, including a mean observed weight gain of approximately 6.5% at 12 weeks, supports continued development of ponsegromab for the treatment of cancer cachexia. Funded by Pfizer. ClinicalTrials.gov: NCT04299048 Citation Format: Jeffrey Crawford, Roberto A. Calle, Susie M. Collins, Yan Weng, Shannon L. Lubaczewski, Clare Buckeridge, Ellen Q. Wang, Magdalena A. Harrington, Anil Tarachandani, Michelle I. Rossulek, James H. Revkin. First-in-patient study of the GDF-15 inhibitor ponsegromab in patients with cancer and cachexia: Safety, tolerability, and exploratory measures of efficacy [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2023; Part 2 (Clinical Trials and Late-Breaking Research); 2023 Apr 14-19; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2023;83(8_Suppl):Abstract nr CT108.

Early impairment of food intake in patients newly diagnosed with cancer.

Patients with gastrointestinal or lung cancer often suffer from a loss of appetite (anorexia), resulting in reduced food intake (hypophagia) and body weight loss. This study evaluated the prevalence of anorexia, hypophagia, pre-cachexia and cachexia in patients with cancer at time of diagnosis. Patients with newly diagnosed gastrointestinal or lung cancers were included. Body mass index (BMI) and weight loss over the prior 6 months were recorded. Patients were assessed for (pre-)cachexia and for anorexia using the Functional Assessment of Anorexia/Cachexia Therapy (FAACT) and a specific anorexia questionnaire (AQ). Energy and protein intake were calculated through food diaries. Patients were considered hypophagic if intake was ≤70% of guideline-recommended levels. Overall, 102 patients [53 male; median age: 67 (range, 21-88) years] were enrolled. Mean BMI (± standard deviation) was 23.1 ± 3.4 kg/m2; average percentage of weight loss was 10.1 ± 7.8%. At diagnosis, 68% (69/102) of patients had cachexia, and 11% (11/102) pre-cachexia. Prevalence of anorexia was 57% (58/102) and 75% (76/102) according to FAACT and AQ, respectively. Forty-eight percent (49/102) of patients had hypophagia. Patients with anorexia had lower daily energy (p = 0.002) and protein intake (p = 0.0257), and greater percentage of weight loss (p = 0.0005). In patients with hypophagia, negative correlations were observed between percentage of weight loss and total daily calorie (r = -0.40; p = 0.01) and protein intake (r = -0.340; p = 0.018). Anorexia, inadequate nutritional intake and cachexia are highly prevalent in patients with gastrointestinal or lung cancer at diagnosis. Negative protein and energy balance may play an important role in the pathogenesis of cachexia. Early multimodal strategies to improve food intake are urgently needed.

Research Application of Patient-Reported Outcomes in Assessing the Nutritional Status of Patients with Gastrointestinal Tumors

Objective: To investigate and analyze the changes of nutritional status in patients undergoing postoperative adjuvant chemotherapy for gastrointestinal tumors based on patient-reported outcomes. Methods: From July 2020 to March 2021, 60 patients with gastrointestinal tumor who received adjuvant chemotherapy for the first time after surgery under the oncology department of a third-level, first-class hospital in Shaanxi Province were recruited by convenience sampling. The patient-reported nutritional evaluation outcomes within 24 hours after admission and during the fourth chemotherapy cycle incorporated nutritional risk screening 2002 (NRS2002), Functional Assessment of Anorexia/Cachexia Therapy (FAACT), psychological pain screening, Generalized Anxiety Disorder Assessment (GAD-7), Patient Health Questionnaire-9 (PHQ-9) to screen for depression, dietary self-assessment, health index scale (EQ-5D), and nutrition supervisor overall assessment scale. Results: The self-reported nutritional evaluation outcomes by adjuvant chemotherapy patients showed an upward trend along with their chemotherapy cycle. Their PG-SGA score, FAACT score, psychological pain score, and EQ-5D score during the fourth cycle were better than those during the first chemotherapy cycle (p &lt; 0.05). Conclusion: Based on the patient-reported nutritional evaluation outcomes, the nutritional status and quality of life of patients with gastrointestinal tumors during chemotherapy did not worsen. Medical staff should timely evaluate the nutritional status of patients with gastrointestinal tumors during chemotherapy and implement reasonable nutritional intervention to improve the quality of life of patients. In the future, patient-reported outcomes should be considered for integration into clinical practice in order to facilitate patient participation in decision-making and improve their medical experience.

Prevalence of Malnutrition in Patients at First Medical Oncology Visit in a Single Center Study

Background: Malnutrition is associated to treatment toxicity, complications, reduced physical function, and lower survival in cancer patients. Malnutrition or associated risk was observed in the Prevalence of Malnutrition in Oncology (PreMiO) study among cancer patients visiting their first medical oncology appointment. Oncologists, not nutritionists, evaluated the nutrition status of the patients in this research, which was a first. Objective: The aim of the study was to evaluate the prevalence of malnutrition in patients at first medical oncology. Methods: PreMiO was a prospective, observational study conducted at Department of oncology, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh. For inclusion, adult patients (&gt;18 years) had a solid tumor diagnosis, were treatment-naive, and had a life expectancy &gt;3 months. Malnutrition was identified by the Mini Nutritional Assessment (MNA), appetite status with a visual analog scale (VAS), and appetite loss with a modified version of Anorexia-Cachexia Subscale (AC/S-12) of the Functional Assessment of Anorexia- Cachexia Therapy (FAACT). Results: Of patients enrolled (N=50), 51% had nutritional impairment; 9% were overtly malnourished, and 43% were at risk for malnutrition. Severity of malnutrition was positively correlated with the stage of cancer. Over 40% of patients were experiencing anorexia, as reported in the VAS and FAACT questionnaire. During the prior six months, 64% of patients lost weight (1–10 kg). Conclusion: Even on their first visit to a medical oncology center, malnutrition, anorexia, and weight loss are prevalent in cancer patients.

Validation of the functional assessment of anorexia/cachexia therapy instrument to assess quality of life in maintenance hemodialysis patients with cachexia.

Many patients on maintenance hemodialysis (MHD) eventually suffer from cachexia. The Functional Assessment of Anorexia/Cachexia Therapy (FAACT) is a tool used to evaluate the quality of life of patients with cachexia related to various diseases, but its suitability for use in MHD patients has yet to be verified. This study aimed to explore the validation of the FAACT in MHD patients by conducting reliability and validity tests. Qualified MHD patients were selected to complete the FAACT and Kidney Disease Quality of Life Short Form 36 (KDQOL-36) questionnaires, and their demographic data and biochemical test results were collected from electronic medical records. Next, the Cronbach's alpha coefficient, paired sample t test and ICC were used to analyze the scale consistency. Additionally, the association between the KDQOL-36 and FAACT was analyzed using Bland-Altman plots and Pearson correlation analysis. Finally, the patients were divided into groups to evaluate discriminant validity. A total of 299 patients were included in this study. The Cronbach's alpha coefficients of the FAACT and its anorexia-cachexia subscale (ACS) were 0.904 and 0.842, respectively, and their ICC exceeded 0.90. The correlation coefficients between the FAACT and its items ranged from 0.146 to 0.631, and the correlation coefficients between the FAACT and KDQOL-36 dimensions ranged from 0.446 to 0.617. The Bland-Altman plots between the FAACT and KDQOL-36 showed that only 3.3% of the points were outside the 95% limits of agreement. The effects of cachexia status (present or absent) on FAACT and ACS scores had effect sizes of 0.54 (P< 0.001) and 0.60 (P< 0.001), respectively. The FAACT and ACS also significantly discriminated between patients with and without inflammation (P< 0.001). The FAACT and ACS have acceptable reliability and validity in MHD patients and are suitable for measuring the quality of life of MHD patients with cachexia.

Nutrition and functional status among Palestinian cancer patients receiving chemotherapy

ObjectivesThis study aims to determine the prevalence of malnutrition among cancer patients and to assess the nutritional and functional status of cancer patients undergoing chemotherapy at the Oncology unit of Beit Jala Governmental Hospital in Palestine. MethodsDuring the data collection period, all patients who received chemotherapy at the hospital's chemotherapy unit were included in this cross-sectional analysis. Anthropometric measurements and biochemical data from the patients' files were used to determine nutritional status. The Nutrition Risk Screening (NRS) 2002 was used to assess the risk of malnutrition. The Functional Assessment of Anorexia/Cachexia Therapy (FAACT) was used to determine functional status. A three-day diet recall was used to determine dietary intake. ResultsA total of 153 patients were included in the final analysis. The results revealed that 23.8% of the patients were at risk of malnutrition. Those who were not at risk of malnutrition had a marginally improved functional position. Furthermore, patients aged ≥65 years, males, smokers or former smokers, and those with four or more comorbidities had a significantly higher prevalence of malnutrition. In the logistic model, age >60 years was the only indicator of malnutrition. ConclusionMalnutrition has a considerable prevalence in the study sample. However, the functional status of patients who were not at risk of malnutrition was marginally better than that of those with malnutrition risk.

Efficacy of horse oil on lipopolysaccharide-induced inflammation in human keratinocyte.

To investigate the efficacy of horse oil on lipopolysaccharide (LPS)-induced inflammation in human keratinocytes. Western blot analysis was performed to measure the expression of cyclooxygenase-2 (COX-2) and IκBα. ELISA was used to analyze prostaglandin E2 (PGE2) levels. Horse oil decreased LPS-induced COX-2 and PGE2 levels in a dose-dependent manner. Nuclear factor-kappa B (NF-κB) plays a key role in the expression of inflammatory cytokines and mediators. Therefore, we investigated the influence of horse oil on the NF-κB signaling pathways. Horse oil inhibited translocation of NF-κB from the cytosol to the nucleus. Furthermore, LPS-induced degradation of IκBα was recovered by horse oil. The activation of p38 mitogen-activated protein kinase (MAPK) reportedly induces degradation of IκBα In agreement with this, LPS activated p38 MAPK and caused IκBα degradation. Conversely, horse oil inhibited LPS-induced p38 MAPK activation and IκBα degradation. In addition, a specific p38 MAPK inhibitor, SB203580, blocked IκBα degradation. Horse oil decreased COX-2 and PGE2 by inhibiting p38 MAPK activation, IκBα degradation, and the translocation of NF-κB.

Cancer-associated anorexia: Validity and performance overtime of different appetite tools among patients at their first cancer diagnosis

Anorexia is a frequent symptom in cancer and we aimed to assess its prevalence among patients at their first cancer diagnosis by different appetite tools and the relationship between each tool with self-reports of food intake. We also tested whether cancer anorexia influences outcomes independently of reduced food intake or body weight loss (BWL) overtime and whether BWL was associated with complications during anticancer-therapy. Functional Assessment of Anorexia/Cachexia Therapy (FAACT) score, self-assessment of appetite, Anorexia Questionnaire (AQ) and Visual Analog Scale (VAS) were administered. Percent of food intake was used as a criterion measure of anorexia. We registered BWL and anticancer-therapy complications over 3-month-follow-up. 438 cancer patients from 7 cancer-centers worldwide were included. The prevalence of anorexia was 39.9% by FAACT score, 40.2% by VAS, 40.6% by the self-assessment of appetite and 65.4% by AQ. Low food intake (≤50%) was reported in 28% of patients. All appetite tools correlated with food intake percent (P<0.0001). We documented a correlation between self-assessment of appetite, FAACT score, VAS and BWL overtime (P<0.04). The self-assessment of appetite (P=0.0152) and the FAACT score (P=0.043) were associated with BWL independently of anticancer therapies. Among patients with BWL, the risk to develop complications was greater with respect to those who maintained a stable or gained body weight (P=0.03). In our sample of cancer patients, FAACT score and self-assessment of appetite performed well when low food intake was used as a criterion measure, and revealed an association of anorexia with BWL, which was, in turn, related to the development of anticancer-therapy complications.

Efficacy and Safety of Yukgunja-Tang for Patients with Cancer-related Anorexia: A Randomized, Controlled Trial, Pilot Study.

Objective:The purpose of this study is both to estimate the efficacy and the safety of Yukgunja-tang (YGJT) and to establish evidence for the use of herbal medicines in the management of patients with cancer-related anorexia.Methods:We enrolled 40 patients with cancer-related anorexia. The enrolled participants were randomly allocated to 2 groups: the control group (n = 20), which received nutrition counseling, and the treatment group (n = 20), which received nutrition counseling and was administered YGJT at twice a day for 4 weeks (a total of 56 times @ 3.0 g each time). The primary outcome of this study was the score on the anorexia/cachexia subscale (ACS) of the Functional Assessment of Anorexia/Cachexia Therapy (FAACT). The secondary outcomes were the FAACT score with the ACS score excluded, the score on the Visual Analog Scale (VAS) for appetite, and the results on laboratory tests regarding appetite, such as leptin, tumor necrosis factors (TNF-α), interleukin-6 (IL-6), and ghrelin. All variables related to the safety assessment, such as vital signs, electrocardiography results, laboratory test results (complete blood cell count, chemistry, urine test), and adverse events, were documented on the case report form (CRF) at every visit.Result:The difference in the primary outcome, that is, the score on the anorexia/cachexia subscale (ACS) of the Functional Assessment of Anorexia/Cachexia Therapy (FAACT), between the control and the treatment groups was statistically significant (P = .023) as was the difference in the FAACT scores with the ACS score excluded, a secondary outcome, between the 2 groups; however, no statistically significant differences were noted in the scores on the VAS or the levels of leptin, TNF-α, IL-6, and ghrelin. In addition, no significant differences in the numbers and the types of adverse events or in the results on the laboratory tests between the control and the treatment groups were recorded.Conclusion:These results obtained in this research confirmed the efficacy and the safety of using YGJT as a herb-medicine treatment option for patients with cancer-related anorexia.

Using a generic definition of cachexia in patients with kidney disease receiving haemodialysis: a longitudinal (pilot) study.

Research indicates that cachexia is common among persons with chronic illnesses and is associated with increased morbidity and mortality. However, there continues to be an absence of a uniformed disease-specific definition for cachexia in chronic kidney disease (CKD) patient populations. The primary objective was to identify cachexia in patients receiving haemodialysis (HD) using a generic definition and then follow up on these patients for 12 months. This was a longitudinal study of adult chronic HD patients attending two hospital HD units in the UK. Multiple measures relevant to cachexia, including body mass index (BMI), muscle mass [mid-upper arm muscle circumference (MUAMC)], handgrip strength (HGS), fatigue [Functional Assessment of Chronic Illness Therapy (FACIT)], appetite [Functional Assessment of Anorexia/Cachexia Therapy (FAACT)] and biomarkers [C-reactive protein (CRP), serum albumin, haemoglobin and erythropoietin resistance index (ERI)] were recorded. Baseline analysis included group differences analysed using an independent t-test, dichotomized values using the χ2 test and prevalence were reported using the Statistical Package for the Social Sciences 24 (IBM, Armonk, NY, USA). Longitudinal analysis was conducted using repeated measures analysis. A total of 106 patients (30 females and 76 males) were recruited with a mean age of 67.6 years [standard deviation (SD) 13.18] and dialysis vintage of 4.92 years (SD 6.12). At baseline, 17 patients were identified as cachectic, having had reported weight loss (e.g. >5% for >6 months) or BMI <20 kg/m2 and three or more clinical characteristics of cachexia. Seventy patients were available for analysis at 12 months (11 cachectic versus 59 not cachectic). FAACT and urea reduction ratio statistically distinguished cachectic patients (P = 0.001). However, measures of weight, BMI, MUAMC, HGS, CRP, ERI and FACIT tended to worsen in cachectic patients. Globally, cachexia is a severe but frequently underrecognized problem. This is the first study to apply the defined characteristics of cachexia to a representative sample of patients receiving HD. Further, more extensive studies are required to establish a phenotype of cachexia in advanced CKD.

The Role of Trigonella, Cichorium, and Foeniculum Herbal Combination in the Treatment of Cancer-Induced Anorexia/Cachexia: A Quasi-Experimental Study

Background: Anorexia and cachexia are one of the major problems in patients suffering from advanced malignancies. Objectives: This study aimed at evaluating the efficacy of herbal combination containing Fenugreek, Fennel, and Chicory supplementation to the high-dose megestrol for the treatment of cancer-induced cachexia and anorexia. Methods: This quasi-experimental study was performed on 47 adult patients with advanced malignancy; they experienced anorexia and weight loss over the 2 past months and referred to a university-affiliated hospital (Omid) in Isfahan, Iran. Patients who had met the inclusion criteria were assigned to take either herbal combination or placebo tablets in addition to megestrol (160 mg daily) for a 2-month follow-up. All patients’ demographic information, weight changes, anthropometric indices, as well as the quality of life criteria were recorded at the baseline and after the duration of follow-up. Results: Patients in the herbal combination group experienced a mean weight gain of 1.5 kg, while patients in the placebo group had an average weight loss of 0.6 kg. Anthropometric indices including triceps skinfold thickness, mid-arm muscle circumference index, and grip strength were significantly improved in the herbal combination group. The other evaluated criteria such as quality of life, functional assessment of anorexia/cachexia therapy (FAACT), and some factors of Anderson criteria were significantly improved in the herbal combination group than the placebo group. Conclusions: Given the ameliorated results of the herbal combination supplementation in terms of weight gain and appetite improvement, as well as physical and quality of life enhancement, it seems that the herbal combination can be used as an adjunctive treatment for the management of patients suffering from cancer-induced cachexia and anorexia.

Quality of life and added value of a tailored palliative care intervention in patients with soft tissue sarcoma undergoing treatment with trabectedin: a multicentre, cluster-randomised trial within the German Interdisciplinary Sarcoma Group (GISG).

ObjectivesThe choice of drug treatment in advanced soft tissue sarcoma (STS) continues to be a challenge regarding efficacy, quality of life (QoL) and toxicity. Unlike other cancer types, where integrating patient-reported outcomes (PRO) has proven to be beneficial for QoL, there is no such evidence in patients with STS as of now. The YonLife trial aimed to explore the effect of a tailored multistep intervention on QoL, symptoms and survival in patients with advanced STS undergoing treatment with trabectedin as well as identifying predictors of QoL.DesignYonLife is a cluster-randomised, open-label, proof-of-concept study. The intervention incorporates electronic PRO assessment, a case vignette and expert-consented treatment recommendations.ParticipantsSix hospitals were randomised to the control arm (CA) or interventional arm (IA). Seventy-nine patients were included of whom 40 were analysed as per-protocol analysis set.Primary and secondary outcome measuresThe primary end point was the change of Functional Assessment for Cancer Therapy (FACT-G) total score after 9 weeks. Secondary outcomes included QoL (FACT-G subscales), anorexia and cachexia (Functional Assessment of Anorexia/Cachexia Therapy (FAACT)), symptoms (MD Anderson Symptom Inventory (MDASI)), anxiety and depression (HADS), pain intensity and interference (Brief Pain Inventory (BPI)) and survival assessment.ResultsAfter 9 weeks of treatment, QoL declined less in the IA (ΔFACT-G total score: −2.4, 95% CI: −9.2 to 4.5) as compared with CA (ΔFACT-G total score: −3.9; 95% CI:−11.3 to 3.5; p=0.765). In almost all FACT-G subscales, average declines were lower in IA, but without reaching statistical significance. Smaller adverse trends between arms were observed for MDASI, FAACT, HADS and BPI scales. These trends failed to reach statistical significance. Overall mean survival was longer in IA (648 days) than in CA (389 days, p=0.110). QoL was predicted by symptom severity, symptom interference, depression and anxiety.ConclusionOur data suggest a potentially favourable effect of an electronic patient-reported outcomes based intervention on QoL that needs to be reappraised in confirmatory studies.Trial registration numberClinicalTrials.gov Identifier (NCT02204111).

Asprosin is associated with anorexia and body fat mass in cancer patients.

Increasing evidence suggests that many adipokines are involved in cancer-related anorexia and cachexia syndrome (CACS), although the underlying mechanism remains to be clarify. Asprosin is a new peptide hormone mainly secreted by white adipose tissues that can increase appetite and body weight. In this cross-sectional study, we tested whether asprosin may intervene in the development of CACS. The fasting plasma asprosin levels were determined via enzyme-linked immune-sorbent assay. Anorexia was determined using the anorexia/cachexia subscale (A/CS) of the functional assessment of anorexia/cachexia therapy (FAACT) questionnaire. The body composition was assessed using bioelectrical impedance analysis. The association of plasma asprosin with anorexia, cachexia, and nutritional status was analyzed. One hundred twenty treatment-naïve patients with pathological confirmed gastrointestinal or lung cancer and 14 mild gastritis patients were recruited. We found no significant difference in asprosin levels between subgroups of patients by age, sex, cancer types or stage. Correlation analysis suggested that asprosin levels were positively associated with body fat mass (r = 0.248, p = 0.043). No correlations were found between asprosin levels and hemoglobin, white blood cell count, blood platelet count, albumin, C-reactive protein, glucose, cholesterol, triglyceride, high density lipoprotein, low density lipoprotein, body mass index, body fat percentage, protein, skeletal muscle, muscle mass, lean body mass, and basal metabolic rate. Furthermore, asprosin levels were not significantly different between patients with or without cachexia. However, patients with anorexia had significantly lower asprosin levels compared with patients without anorexia. No significant difference in asprosin levels between gastritis and gastric cancer patients. Similarly, no significant change of asprosin levels occurred postoperatively in 10 gastric cancer patients. Patients with anorexia had significantly lower asprosin levels compared with patients without anorexia. We therefore speculated that asprosin might intervene in the development of cancer anorexia and serve as a potential therapeutic target.

Symptom Burden in Patients With Home Care Who Are at Risk for Malnutrition: A Cross-Sectional Study.

In Sweden, patients in early palliative stages of illness are cared for in primary care and often offered home care. Many are older and at risk for malnutrition, but little is known about their symptom burden and nutritional problems. This cross-sectional study divided older patients in home care into those with and without risk for malnutrition and compared symptom burden in the 2 groups. Participants were patients in Stockholm County (n = 121) in early palliative stages of disease cared for at home by primary care professionals from 10 health-care centers. The Mini Nutritional Assessment (MNA) was used to identify risk for malnutrition. Symptoms and/or nutritional status in patients with and without risk were assessed with the Functional Assessment of Anorexia/Cachexia Therapy (FAACT), Patient-Generated Subjective Global Assessment Short Form (PG-SGA), and Edmonton Symptom Assessment System (ESAS). Forty-two percent of the patients were at risk for malnutrition (MNA). Appetite (P = .012), tiredness (P = .003), and anxiety (P = .008) were worse in these patients than in those without risk (ESAS; significance level, P ≤ .015). Patients at risk were also more concerned about how thin they looked (P = .006), agreed more strongly that their family or friends were pressuring them to eat (P = .000; FAACT; significance level, P ≤ .029), had a higher symptom burden (P = .005), had lower physical activity (P = .000), and more lost weight over time (P = .032; PG-SGA; significance level, P ≤ .040). This study adds a more detailed picture of the symptom burden in older patients at risk for malnutrition. Such information is needed to identify risk for malnutrition earlier and improve patients' health.

Identifying Malnutrition in End-stage Renal Disease (ESRD) (P12-037-19)

ObjectivesMalnutrition and appetite disturbances, such as anorexia, are commonly reported amongst hemodialysis patients. Nutrition management is a complex issue in ESRD and greater understanding is needed into the associated clinical mediators in ESRD. However, there is currently limited data on anorexia and the pathophysiology framework involved.The aim of this study was to assess the relationship between appetite score and associated clinical biomarkers as a means to identify malnutrition. This work is part of an ongoing international multicenter effort to better define and develop treatment strategies for cachexia in patients with ESRD. MethodsA cross-sectional analysis study included 106 patients from two hemodialysis (HD) units within the United Kingdom (U.K). Appetite score was assessed using the Functional Assessment of Anorexia/Cachexia Therapy (FAACT). Clinical bio-makers included Body Mass Index (BMI), Albumin and C-reactive protein (CRP). Correlations between FAACT and clinical bio-markers were determined using Spearman’s rho for non-normally distributed scales. ResultsThere was no significant relationship between FAACT and albumin levels (r = 0.14; P = 0.16) or BMI (r = 0.28; P = .19). However, there was a moderate and significant negative correlation between FAACT and CRP levels (r = 0.31; P < 0.001) indicating an inverse relationship between appetite (e.g., decreased FAACT score) and CRP levels (e.g., higher inflammation). ConclusionsWe found a significant and incremental relationship between inflammation and anorexia which is supported by previous research. The FAACT may be a useful tool in identifying patients at higher risk of malnutrition-inflammation cachexia syndrome which has been associated with higher hospitalization and morality rates. Nutritional status and inflammation are important aspects of clinical practice in ESRD. A more focused approach to anorexia in ESRD is warranted. Funding SourcesThis study was funded by the Public Health Agency (Ref: STL/5179/15) and the Northern Ireland Kidney Research Fund. Noble et al., was funded by the National Institute for Health Research and the Health and Social Care Research and Development Division of the Public Health Agency Office Northern Ireland NIHR (CDV/4872/13).

Comprehensive validation of the functional assessment of anorexia/cachexia therapy (FAACT) anorexia/cachexia subscale (A/CS) in lung cancer patients with involuntary weight loss.

Comprehensive (qualitative and quantitative) assessments of the 12-item functional assessment of anorexia/cachexia therapy (FAACT) anorexia/cachexia subscale (A/CS) and relevant subscales were undertaken for use in constructing potential endpoints in clinical trials of non-small cell lung cancer (NSCLC) with involuntary weight loss. Eleven participants (≥ 18years) from six clinical sites with a diagnosis of stage III unresectable or stage IV NSCLC and involuntary weight loss (either ≥ 5% body weight loss within six months prior to screening or screening BMI < 20kg/m2) were interviewed to evaluate the content validity of the A/CS domain. A psychometric evaluation was conducted on the A/CS domain, and symptoms and concerns subscales, using data from previously completed phase III clinical trials (ROMANA1 [N = 474] and ROMANA2 [N = 488]). Anorexia-related symptoms were highly relevant to participants and had important impacts on their lives including energy levels, and physical, social, and psychological functioning. The majority of participants endorsed the A/CS domain items and found them to be easily understood, relevant, and comprehensive. Confirmatory factor analyses established that the A/CS symptoms and concerns subscales provided an acceptable fit as single factor models in ROMANA1 and ROMANA2. Reliability, validity, and responsiveness were established for the 12item A/CS domain, 5item anorexia symptoms subscale, and 4-item anorexia concerns subscale. These scales have good content validity, favorable psychometric properties, and can be used for characterizing the effect of treatment on anorexia symptoms and/or anorexia-related concerns in patients with NSCLC.