Cancer Cachexia Clinical Trial
Official title:
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
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.
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. ;
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