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.