NCT01505764

The Role of Ghrelin in Cancer Cachexia

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: VA Office of Research and Development · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Cancer Cachexia

Interventions

Type	Name	Description
DRUG	Anamorelin HCl	100 mg tablets; oral administration every day for 84 days, at least 1 hour before the first meal of the day.
DRUG	Placebo	Placebo tablets identical in appearance to active tablets; oral administration once a day for 84 days, at least 1 hour before the first meal of the day.

Timeline

• Start date: 2012-06-01
• Primary completion: 2016-01-01
• Completion: 2016-03-01
• First posted: 2012-01-09
• Last updated: 2018-07-17
• Results posted: 2017-02-24

Locations

1 site across 1 country: United States