Cancer Cachexia Clinical Trial
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.
Status | Completed |
Enrollment | 80 |
Est. completion date | October 2006 |
Est. primary completion date | October 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Community-dwelling patients = 18 years of age with incurable, histologically diagnosed cancer. - Involuntary loss of body weight of = 5 % within the past 6 months Exclusion Criteria: - 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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Cancer Outreach Associates | Abingdon | Virginia |
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | Fletcher Allen Health Care | Burlington | Vermont |
United States | University of Texas Medical Branch at Galveston | Galveston | Texas |
United States | California Cancer Care Center | Greenbrae | California |
United States | Michael E. DeBakey Veterans Affairs Medical Center | Houston | Texas |
United States | Columbia University Medical Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Helsinn Therapeutics (U.S.), Inc |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Body Weight | |||
Primary | Lean Body Mass | |||
Primary | Functional Performance |
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