The Role of Ghrelin in Cancer Cachexia
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 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 you are burning), functional performance, safety and tolerability of Anamorelin HCl.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||The Role of Ghrelin in Cancer Cachexia|
- Total body potassium. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Body composition as measured by Densitometry. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Muscle strength as measured by grip strength. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Body weight. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Quality of life. [ Time Frame: 2 years ] [ Designated as safety issue: No ]Quality of life as assessed using the ASAS, EQ-5D and FACIT-F, Patient Reported Outcome assessments
- Appetite. [ Time Frame: 2 years ] [ Designated as safety issue: No ]Appetite measured by a visual analogue scale and a food diary.
- Resting energy expenditure. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Functional performance. [ Time Frame: 2 years ] [ Designated as safety issue: No ]Functional performance using stair-climbing power, 6-minute walk, tests of the major muscle groups and 24 hour physical activity levels
- Body composition. [ Time Frame: 2 years ] [ Designated as safety issue: No ]Body composition as measured by Total body nitrogen and bioimpedance.
- Safety and tolerability. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]The safety and tolerability of Anamorelin HCl assessed through the number of participants with Adverse Events.
- Biomarkers TNF-alpha, IL-6, IGF-1 and IGFBP-3. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||June 2012|
|Estimated Study Completion Date:||March 2016|
|Estimated Primary Completion Date:||January 2016 (Final data collection date for primary outcome measure)|
Experimental: Arm 1
Drug: Anamorelin HCl
100 mg tablets; oral administration every day for 84 days, at least 1 hour before the first meal of the day.
Placebo Comparator: Arm 2
Placebo tablets identical in appearance to active tablets; oral administration QD for 84 days, at least 1 hour before the first meal of the day.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01505764
|United States, Texas|
|Michael E. DeBakey VA Medical Center, Houston, TX|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Jose M. Garcia, MD PhD||Michael E. DeBakey VA Medical Center, Houston, TX|