Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Cancer Cachexia
Both
Cancer Cachexia
Trial Information
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Outcome Measure:
Body Weight
Principal Investigator
William Polvino, MD
Investigator Role:
Study Director
Investigator Affiliation:
Sapphire Therapeutics
Authority:
United States: Food and Drug Administration
Study ID:
RC-1291-203
NCT ID:
NCT00219817
Start Date:
June 2005
Completion Date:
October 2006
Related Keywords:
- Cancer Cachexia
- Anorexia
- Cachexia
- Cachexia
Name | Location |
|---|---|
| Fletcher Allen Health Care | Burlington, Vermont 05401 |
| Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
| Columbia University Medical Center | New York, New York 10032 |
| Cancer Outreach Associates | Abingdon, Virginia 24211 |
| California Cancer Care Center | Greenbrae, California 94904 |
| University of Texas Medical Branch at Galveston | Galveston, Texas 77555 |
| Michael E. DeBakey Veterans Affairs Medical Center | Houston, Texas 77030 |
