Clinical Trials Logo

Clinical Trial Summary

Cancer is often coupled with a condition called cachexia. In this condition, individuals continue to lose weight and lean body mass, which means their muscles are getting smaller and weaker. Studies have shown that cancer patients who are losing weight often are responding poorly to chemotherapy, are at greater risk of infection and have a reduced life expectancy. Also, people may not want to eat. To date, there are no approved treatments available for this condition.

This study is going to study the benefits of the use of the study drug, Anamorelin hydrochloride (HCl) in treatment or prevention of cachexia associated with cancer. Studies done before with the study drug have shown that the drug can help the cachectic condition. The purpose of this research study is to evaluate the effectiveness of Anamorelin HCl compared to placebo on body composition (amount of cell mass, fat, muscle, etc.) including measurements of body potassium and nitrogen stores.

In addition to the above, the study will also assess the effect of the study drug on handgrip strength, body weight, lean muscle mass, quality of life, appetite & food intake, certain blood markers, energy expenditure (the amount of energy participants burn), functional performance, safety and tolerability of Anamorelin HCl.


Clinical Trial Description

Subjects enrolled in the study will be randomly chosen to receive either Anamorelin HCL at a dose of 100 mg per day for 12 weeks or matching placebo. The chances of receiving anamorelin or placebo are 1 in 2. Which subject receives anamorelin or placebo will be decided at random. Neither the subject nor the study doctor will know which study drug the subject is receiving. The subject will be asked to visit the clinic at Day 1, Day 28, Day 56 and Day 84. There will also be a Day 112 follow-up visit and the medical records will be checked after that to see how the subjects are doing. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01505764
Study type Interventional
Source VA Office of Research and Development
Contact
Status Terminated
Phase Phase 2
Start date June 2012
Completion date March 2016

See also
  Status Clinical Trial Phase
Recruiting NCT02553187 - A Prospective, Randomized, Controlled, Multicenter Study of Kanglaite Injection for the Treatment of Cancer Cachexia Phase 4
Recruiting NCT02848807 - Chemotherapy-related Toxicity, Nutritional Status and Quality of Life N/A
Active, not recruiting NCT01206335 - Open Label Study With OHR/AVR118 in Advanced Cancer Patients With Anorexia-Cachexia Phase 2
Completed NCT00378131 - Placebo Controlled, Randomized Safety and Efficacy Study of RC-1291 in Cancer Anorexia/Cachexia Phase 2
Completed NCT02359123 - Cannabics Capsules as Treatment to Improve Cancer Related CACS in Advanced Cancer Patients N/A
Completed NCT00267358 - Placebo Controlled, Randomized Safety and Efficacy Study of RC-1291 in Cancer Anorexia/Cachexia. Phase 2
Completed NCT03144128 - Vitamin D for Muscle Metabolic Function in Cancer Cachexia N/A
Completed NCT01614990 - Pilot Clinical Trial of Repeated Doses of Macimorelin to Assess Safety and Efficacy in Patients With Cancer Cachexia Phase 2
Recruiting NCT04067167 - Flexi Band Resistance Training Versus EMS Exercise in Patients With the Diagnosis of Malignant Diseases N/A
Recruiting NCT04065815 - Protein-rich Nutritional Therapy Combined With Time-efficient Exercise in Cancer Therapy N/A
Active, not recruiting NCT03851133 - Florida Pancreas Collaborative Next Generation Biobank
Completed NCT05264038 - A First in Human Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics Effects of OC514 Phase 1
Recruiting NCT04127981 - Medical Imaging of Cachexia N/A
Not yet recruiting NCT05262192 - Nutrition Education and Quality of Life in Cancer Cachexia N/A
Completed NCT04153019 - PSYCHO-EDUCATIONAL AND REHABILITATIVE INTERVENTION FOR CANCER CACHEXIA (PRICC) N/A
Terminated NCT02066363 - Study of Parenteral Nutrition to Patients With Gastrointestinal Cancer N/A
Completed NCT00219817 - Safety and Efficacy of RC-1291 HCl in Patients With Cancer Related Anorexia and Weight Loss Phase 2
Completed NCT00094562 - A Fish Oil Supplement to Maintain Body Weight in Patients With Disease-Related Weight Loss Phase 2
Recruiting NCT04131478 - Effect of Gene Polymorphisms on the Pathogenesis of Cancer Cachexia
Recruiting NCT05915325 - Physical Training for Elderly Cancer Patients With Cachexia N/A