Safety and Efficacy of RC-1291 HCl in Patients With Cancer Related Anorexia and Weight Loss
- Conditions
- Cancer Cachexia
- Registration Number
- NCT00219817
- Lead Sponsor
- Helsinn Therapeutics (U.S.), Inc
- Brief Summary
Anorexia and weight loss are devastating complications in late-stage cancer patients and is strongly associated with mortality in these patients. Activation of Ghrelin receptors have been demonstrated to stimulate appetite. RC-1291 HCl, by virtue of its ghrelin like activity and Growth Hormone releasing effects may have a dual role in the reversal of cancer induced anorexia and weight loss. This study will test the safety and efficacy of RC-1291 in the treatment of cancer patients with anorexia and weight loss.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
- Community-dwelling patients ≥ 18 years of age with incurable, histologically diagnosed cancer.
- Involuntary loss of body weight of ≥ 5 % within the past 6 months
- Presently hospitalized or in a nursing care facility.
- Inability to increase food intake from secondary causes.
- Liver disease
- If female-pregnant, breast-feeding or of childbearing potential.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Body Weight Lean Body Mass Functional Performance
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (7)
California Cancer Care Center
🇺🇸Greenbrae, California, United States
Cancer Outreach Associates
🇺🇸Abingdon, Virginia, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
University of Texas Medical Branch at Galveston
🇺🇸Galveston, Texas, United States
Fletcher Allen Health Care
🇺🇸Burlington, Vermont, United States
Michael E. DeBakey Veterans Affairs Medical Center
🇺🇸Houston, Texas, United States