Prevalence and impact of hypogonadism in cancer patients with severe muscle wasting in phase IIb enobosarm trial.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e19582-e19582
Author(s):  
Mitchell S. Steiner ◽  
Adrian Dobs ◽  
Mary Ann Johnston ◽  
Michael L. Hancock ◽  
Ronald A. Morton ◽  
...  
Keyword(s):  
Weight Loss ◽  
Physical Function ◽  
Cancer Patients ◽  
Muscle Wasting ◽  
Controlled Trial ◽  
Performance Status ◽  
Lymphocytic Leukemia ◽  
Double Blind ◽  
Poor Outcomes ◽  
Multi Center Study

e19582 Background: Hypogonadism has been associated with weight loss and poor outcomes in cancer patients. Up to 50% of males with advanced cancer are hypogonadal at presentation or during the course of treatment. Wasting in cancer patients has also been associated with a decline in physical function and performance status and has major public health significance. We conducted a Phase IIb randomized, double blind, placebo controlled, multi-center study to evaluate the effect of enobosarm on muscle wasting and physical function in cancer patients. Methods: Patients (n=159) were randomized to oral enobosarm (1 or 3 mg) or placebo daily for 16 wks. Patients were males >45 y and postmenopausal females, had ≥2% weight loss in the 6 mths prior to randomization, BMI <35 and either NSCLC, colorectal cancer, non-Hodgkins lymphoma, chronic lymphocytic leukemia or breast cancer. We report on the incidence and impact of hypogonadism (T<300 ng/dL) in this population. Results: Baseline testosterone levels were available for 93 of 103 men. 60% of male patients were hypogonadal at randomization. Distribution of hypogonadism was similar across cancers; however hypogonadal men were less likely to complete the study. Baseline T levels were positively correlated with weight loss (r=0.32, p=0.002,) with hypogonadal men demonstrating greater weight loss in the previous six months (median, -9.5%). Baseline physical function as measured by stair climb power was higher among eugonadal males compared to hypogonadal males (84.5 watts vs 70.6 watts; p=0.016). Enobosarm significantly improved physical function in this population regardless of baseline gonadal status (hypogonadal: 18.7%, p=0.0061; eugonadal: 13.2%, p=0.0032). The magnitude of improvement was greater in hypogonadal men. Conclusions: Hypogonadism is common in male cancer patients and is correlated with weight loss and diminished physical function. In this randomized, placebo controlled trial, enobosarm improved physical function in both hypogonadal and eugonadal men despite poorer baseline physical function in hypogonadal patients. These data provide evidence that enobosarm may play an important role in the management of cancer related muscle wasting.

Effect of enobosarm on physical function in cancer patients with < or ≥ 5% weight loss in a phase IIb trial.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e19585-e19585
Author(s):  
Shontelle Dodson ◽  
Mary Ann Johnston ◽  
Michael L. Hancock ◽  
Mitchell S. Steiner
Keyword(s):  
Weight Loss ◽  
Physical Function ◽  
Cancer Patients ◽  
Muscle Wasting ◽  
Early Stage ◽  
Lymphocytic Leukemia ◽  
Double Blind ◽  
Baseline Weight ◽  
Clinical Consequences ◽  
Multi Center Study

e19585 Background: Although cachexia has been defined as >5% weight loss, limited data exists on the prevention and treatment of muscle wasting prior to a patient becoming cachectic. Cancer induced muscle wasting can begin early in the course of a patient’s malignancy resulting in decline in physical function and other detrimental clinical consequences including less tolerability to chemotherapy, worse outcomes, and shorter survival - underscoring the importance of diagnosing and treating this condition at an early stage. Methods: We conducted a randomized, double blind, placebo controlled, multi-center study to evaluate the effect of enobosarm on physical function and muscle wasting in cancer patients. Subjects (n=159) were randomized to oral enobosarm or placebo for 16 weeks. Subjects were males >45y and postmenopausal females, with ≥2% weight loss in the 6 months prior to randomization and diagnosed with NSCLC, colorectal cancer, non-Hodgkin’s lymphoma, chronic lymphocytic leukemia or breast cancer. We report on changes in physical function based on weight loss of < or ≥5%in the 6 months prior to randomization. Results: 103 subjects (MITT) had physical function assessed by stair climb at baseline and week 16 with 24% losing <5% weight in the previous 6 months. Distribution of weight loss was similar across genders, however subjects with <5% weight loss were more likely to be ECOG=0 (<5% loss: 46.2%; ≥5% loss: 35.8%). Subjects with ≥5% weight loss had worse physical function at baseline compared to those with <5% loss (p=0.048). A significant improvement in physical function was observed in subjects that received enobosarm regardless of baseline weight loss (<5% loss, p=0.041, ≥5% loss, p<0.001) while subjects that received placebo failed to improve. Conclusions: Enobosarm was generally well tolerated and showed a statistically significant improvement in physical function in cancer subjects regardless of baseline weight loss. These data provide evidence that enobosarm may play an important role in the management of cancer patients by not only treating, but also preventing further decline in physical function and muscle wasting before a patient becomes cachectic.

scholarly journals Deterioration in Muscle Mass and Physical Function Differs According to Weight Loss History in Cancer Cachexia

Cancers ◽  
2019 ◽  
Vol 11 (12) ◽  
pp. 1925 ◽  
Author(s):  
Guro Birgitte Stene ◽  
Trude Rakel Balstad ◽  
Anne Silja M. Leer ◽  
Asta Bye ◽  
Stein Kaasa ◽  
...  
Keyword(s):  
Weight Loss ◽  
Physical Function ◽  
Muscle Mass ◽  
Cancer Cachexia ◽  
Karnofsky Performance Status ◽  
Handgrip Strength ◽  
Controlled Trial ◽  
Performance Status ◽  
Secondary Analysis ◽  
Primary Endpoints

Background: Muscle mass and physical function (PF) are common co-primary endpoints in cancer cachexia trials, but there is a lack of data on how these outcomes interact over time. The aim of this secondary analysis of data from a trial investigating multimodal intervention for cancer cachexia (ClinicalTrials.gov: NCT01419145) is to explore whether changes in muscle mass and PF are associated with weight loss and cachexia status at baseline. Methods: Secondary analysis was conducted using data from a phase II randomized controlled trial including 46 patients with stage III–IV non-small cell lung cancer (n = 26) or inoperable pancreatic cancer (n = 20) due to commence chemotherapy. Cachexia status at baseline was classified according to international consensus. Muscle mass (assessed using computed tomography (CT)) and PF outcomes, i.e., Karnofsky performance status (KPS), self-reported PF (self-PF), handgrip strength (HGS), 6-minute walk test (6MWT), and physical activity (PA), were measured at baseline and after six weeks. Results: When compared according to cachexia status at baseline, patients with no/pre-cachexia had a mean loss of muscle mass (−5.3 cm2, p = 0.020) but no statistically significant change in PF outcomes. Patients with cachexia also lost muscle mass but to a lesser extent (−2.8 cm2, p = 0.146), but demonstrated a statistically significant decline in PF; KPS (−3.8 points, p = 0.030), self-PF (−8.8 points, p = 0.027), and HGS (−2.7 kg, p = 0.026). Conclusions: Weight loss history and cachexia status at baseline are of importance if one aims to detect changes in PF outcomes in cancer cachexia trials. To improve the use of co-primary endpoints that include PF in future trials, outcomes that have the potential to detect change relative to weight loss should be investigated further.

scholarly journals Effect of liraglutide on body weight and pain in patients with overweight and knee osteoarthritis: protocol for a randomised, double-blind, placebo-controlled, parallel-group, single-centre trial

BMJ Open ◽  
2019 ◽  
Vol 9 (5) ◽  
pp. e024065 ◽  
Author(s):  
Henrik Gudbergsen ◽  
Marius Henriksen ◽  
Eva Ejlersen Wæhrens ◽  
Anders Overgaard ◽  
Henning Bliddal ◽  
...  
Keyword(s):  
Weight Loss ◽  
Body Weight ◽  
Knee Osteoarthritis ◽  
Controlled Trial ◽  
Single Centre ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Knee Oa ◽  
Parallel Group ◽  
Pain Subscale

IntroductionWith an increasing prevalence of citizens of older age and with overweight, the health issues related to knee osteoarthritis (OA) will intensify. Weight loss is considered a primary management strategy in patients with concomitant overweight and knee OA. However, there are no widely available and feasible methods to sustain weight loss in patients with overweight and knee OA. The present protocol describes a randomised controlled trial evaluating the efficacy and safety of the glucagon-like peptide-1 receptor agonist liraglutide in a 3 mg/day dosing in patients with overweight and knee OA.Methods and analysis150 volunteer adult patients with overweight or obesity and knee OA will participate in a randomised, double-blind, placebo-controlled, parallel-group and single-centre trial. The participants will partake in a run-in diet intervention phase (week −8 to 0) including a low calorie diet and dietetic counselling. At week 0, patients will be randomised to either liraglutide 3 mg/day or liraglutide placebo 3 mg/day for 52 weeks as an add-on to dietetic guidance on re-introducing regular foods and a focus on continued motivation to engage in a healthy lifestyle. The co-primary outcomes are changes in body weight and the Knee Injury and Osteoarthritis Outcome Score pain subscale from week 0 to week 52.Ethics and disseminationThe trial has been approved by the regional ethics committee in the Capital Region of Denmark, the Danish Medicines Agency and the Danish Data Protection Agency. An external monitoring committee (The Good Clinical Practice Unit at Copenhagen University Hospitals) will oversee the trial. The results will be presented at international scientific meetings and through publications in peer-reviewed journals.Trial registration numbers2015-005163-16,NCT02905864, U1111-1171-4970Based on protocol versionV.6; 30 January 2017, 15:30 hours

A randomized, double‐blind, placebo‐controlled trial to evaluate the role of curcumin in prostate cancer patients with intermittent androgen deprivation

The Prostate ◽  
2019 ◽  
Vol 79 (6) ◽  
pp. 614-621 ◽  
Author(s):  
Young Hyo Choi ◽  
Deok Hyun Han ◽  
Seon‐woo Kim ◽  
Min‐Ji Kim ◽  
Hyun Hwan Sung ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Cancer Patients ◽  
Controlled Trial ◽  
Androgen Deprivation ◽  
Double Blind ◽  
Double Blind Placebo

scholarly journals Continued Weight Loss and Sarcopenia Predict Poor Outcomes in Locally Advanced Pancreatic Cancer Treated with Chemoradiation

Cancers ◽  
2019 ◽  
Vol 11 (5) ◽  
pp. 709 ◽  
Author(s):  
Patrick Naumann ◽  
Jonathan Eberlein ◽  
Benjamin Farnia ◽  
Thilo Hackert ◽  
Jürgen Debus ◽  
...  
Keyword(s):  
Skeletal Muscle ◽  
Pancreatic Cancer ◽  
Weight Loss ◽  
Muscle Mass ◽  
Muscle Wasting ◽  
Statistical Tests ◽  
Locally Advanced ◽  
Advanced Pancreatic Cancer ◽  
Skeletal Muscle Index ◽  
Poor Outcomes

Background: Surgical resection offers the best chance of survival in patients with pancreatic cancer, but those with locally advanced disease (LAPC) are usually not surgical candidates. This cohort often receives either neoadjuvant chemotherapy or chemoradiation (CRT), but unintended weight loss coupled with muscle wasting (sarcopenia) can often be observed. Here, we report on the predictive value of changes in weight and muscle mass in 147 consecutive patients with LAPC treated with neoadjuvant CRT. Methods: Clinicopathologic data were obtained via a retrospective chart review. The abdominal skeletal muscle area (SMA) at the third lumbar vertebral body was determined via computer tomographic (CT) scans as a surrogate for the muscle mass and skeletal muscle index (SMI) calculated. Uni- and multi-variable statistical tests were performed to assess for impact on survival. Results: Weight loss (14.5 vs. 20.3 months; p = 0.04) and loss of muscle mass (15.1 vs. 22.2 months; p = 0.007) were associated with poor outcomes. The highest survival was observed in patients who had neither cachectic weight loss nor sarcopenia (27 months), with improved survival seen in those who ultimately received a resection (23 vs. 10 months; p < 0.001). Cox regression revealed that either continued weight loss or continued muscle wasting (SMA reduction) was predictive of poor outcomes, whereas a sarcopenic SMI was not. Conclusions: Loss of weight and lean muscle in patients with LAPC is prognostic when persistent. Therefore, both should be assessed longitudinally and considered before surgery.

scholarly journals Effects of Melatonin on Appetite and Other Symptoms in Patients With Advanced Cancer and Cachexia: A Double-Blind Placebo-Controlled Trial

2013 ◽  
Vol 31 (10) ◽  
pp. 1271-1276 ◽  
Author(s):  
Egidio Del Fabbro ◽  
Rony Dev ◽  
David Hui ◽  
Lynn Palmer ◽  
Eduardo Bruera
Keyword(s):  
Quality Of Life ◽  
Weight Loss ◽  
Advanced Cancer ◽  
Interim Analysis ◽  
Null Hypothesis ◽  
Controlled Trial ◽  
Double Blind ◽  
Patients With Cancer ◽  
Edmonton Symptom Assessment Scale

Purpose Prior studies have suggested that melatonin, a frequently used integrative medicine, can attenuate weight loss, anorexia, and fatigue in patients with cancer. These studies were limited by a lack of blinding and absence of placebo controls. The primary purpose of this study was to compare melatonin with placebo for appetite improvement in patients with cancer cachexia. Patients and Methods We performed a randomized, double-blind, 28-day trial of melatonin 20 mg versus placebo in patients with advanced lung or GI cancer, appetite scores ≥ 4 on a 0 to 10 scale (10 = worst appetite), and history of weight loss ≥ 5%. Assessments included weight, symptoms by the Edmonton Symptom Assessment Scale, and quality of life by the Functional Assessment of Anorexia/Cachexia Therapy (FAACT) questionnaire. Differences between groups from baseline to day 28 were analyzed using one-sided, two-sample t tests or Wilcoxon two-sample tests. Interim analysis halfway through the trial had a Lan-DeMets monitoring boundary with an O'Brien-Fleming stopping rule. Decision boundaries were to accept the null hypothesis of futility if the test statistic z < 0.39 (P ≥ .348) and reject the null hypothesis if z > 2.54 (P ≤ .0056). Results After interim analysis of 48 patients, the study was closed for futility. There were no significant differences between groups for appetite (P = .78) or other symptoms, weight (P = .17), FAACT score (P = .95), toxicity, or survival from baseline to day 28. Conclusion In cachectic patients with advanced cancer, oral melatonin 20 mg at night did not improve appetite, weight, or quality of life compared with placebo.

scholarly journals EFFICACY AND SAFETY OF STANDARDIZED CINNAMON BARK EXTRACT FOR THE PREVENTION OF CHEMOTHERAPY-INDUCED WEIGHT LOSS AND ALOPECIA IN PATIENTS WITH BREAST CANCER: A RANDOMIZED, DOUBLE-BLIND, AND PLACEBO-CONTROLLED STUDY

2019 ◽  
pp. 163-168
Author(s):  
AJAY MEHTA ◽  
SUCHITRA MEHTA ◽  
PRASAD THAKURDESAI
Keyword(s):  
Breast Cancer ◽  
Weight Loss ◽  
Side Effects ◽  
Cancer Patients ◽  
Outcome Measures ◽  
Bark Extract ◽  
Efficacy And Safety ◽  
Breast Cancer Patients ◽  
Double Blind ◽  
Cinnamon Bark

Objective: The objective of the study was to evaluate the effects of IND02 (standardized Cinnamon bark extract) supplementation for the prevention of side effects of cancer chemotherapy in female patients with breast cancer. Methods: The study was conducted using double-blind, placebo-controlled design in 34 female breast cancer patients during the first 4 consecutive 21-day cycles of the standard chemotherapy regimen. The active treatment (IND02 capsules, 400 mg, one capsule, and thrice a day) or matching placebo was orally administrated in randomized (1:1 ratio) patients. The efficacy outcome measures were reduction in chemotherapy-induced weight loss, alopecia (hair fall), and other side effects. The safety outcome measures were hematology, ECG, vital signs, adverse event monitoring, and laboratory safety measurements. Results: The patients on the treatment with IND02 had shown significant protection from chemotherapy-induced severe weight loss (cachexia) and alopecia (reduced hair density and % hairs in the anagen phase, and increased % hairs in telogen phase) which was seen in the placebo group. IND02 treatment was found safe and well-tolerated during the study. Conclusion: Concomitant use of IND02 in breast cancer patients during breast cancer chemotherapy showed a clinical promise regarding efficacy and safety in preventing chemotherapy-induced weight loss and alopecia.

scholarly journals Antifibrinolytic Therapy and Perioperative Blood Loss in Cancer Patients Undergoing Major Orthopedic Surgery

2003 ◽  
Vol 98 (2) ◽  
pp. 337-342 ◽  
Author(s):  
David Amar ◽  
Florence M. Grant ◽  
Hao Zhang ◽  
Patrick J. Boland ◽  
Denis H. Leung ◽  
...  
Keyword(s):  
Blood Loss ◽  
Cancer Patients ◽  
Orthopedic Surgery ◽  
Controlled Trial ◽  
Caproic Acid ◽  
Double Blind ◽  
Perioperative Blood Loss ◽  
Transfusion Requirements ◽  
Major Orthopedic Surgery ◽  
Duration Of Surgery

Background Aprotinin has been reported to reduce blood loss and transfusion requirements in patients having major orthopedic operations. Data on whether epsilon amino-caproic acid (EACA) is effective in this population are sparse. Methods Sixty-nine adults with malignancy scheduled for either pelvic, extremity or spine surgery during general anesthesia entered this randomized, double-blind, placebo-controlled trial, and received either intravenous aprotinin (n = 23), bolus of 2 x 10(6) kallikrein inactivator units (KIU), followed by an infusion of 5 x 10(5) KIU/h, or EACA (n = 22), bolus of 150 mg/kg, followed by a 15 mg/kg/h infusion or saline placebo (n = 24) during surgery. Our goal was to determine whether prophylactic EACA or aprotinin therapy would reduce perioperative blood loss (intraoperative + first 48h) &gt;30% when compared to placebo. Results The mean age of the study population was 52 +/- 17 yr. The groups did not differ in age, duration of surgery, perioperative blood loss or number of packed erythrocyte units transfused. When compared to the placebo group, the two treated groups had a significantly lower D-Dimer level immediately after surgery, P &lt; 0.01. Conclusions Under the conditions of this study, we were unable to find a clinical benefit to using aprotinin or EACA to reduce perioperative blood loss or transfusion requirements during major orthopedic surgery in cancer patients.

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