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Sponsors and Collaborators: |
North Central Cancer Treatment Group National Cancer Institute (NCI) National Cancer Institute of Canada |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00031707 |
RATIONALE: Megestrol and /or an omega-3 fatty acid-enriched nutritional supplement may improve cancer-related weight loss and lack of appetite. It is not yet known whether megestrol alone, an omega-3 fatty acid-enriched nutritional supplement alone, or a combination of both is most effective in treating cancer-related weight loss and loss of appetite.
PURPOSE: Randomized phase III trial to compare the effectiveness of megestrol with or without an omega-3 fatty acid-enriched nutritional supplement to that of the omega-3 fatty acid-enriched nutritional supplement alone in treating patients who have cancer-related weight loss and lack of appetite.
Condition | Intervention | Phase |
---|---|---|
Cancer-Related Problem/Condition |
Drug: megestrol acetate Drug: omega-3 fatty acids |
Phase III |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Open Label, Active Control |
Official Title: | Phase III Double-Blind, Placebo-Controlled Randomized Comparison of Megestrol Acetate (Megace) Versus an N-3 Fatty Acid (EPA) Enriched Nutritional Supplement Versus Both for the Treatment of Cancer Cachexia and Anorexia |
Study Start Date: | March 2000 |
OBJECTIVES:
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to primary cancer (lung vs gastrointestinal vs other), severity of weight loss in the past 2 months (less than 10 pounds vs 10 pounds or more), planned concurrent chemotherapy (yes vs no), age (under 50 vs 50 and over), and prognosis (good vs bad vs unsure). Patients are randomized to 1 of 3 treatment arms.
Treatment continues in the absence of unacceptable toxicity and as long as the patient and physician feel it is beneficial.
Quality of life is assessed at baseline, weekly for 1 month, and then monthly thereafter during study treatment.
Patients are followed every 6 months for 5 years.
PROJECTED ACCRUAL: A total of 450 patients (150 per treatment arm) will be accrued for this study within 15 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically proven cancer other than brain, breast, ovarian, endometrial, or prostate cancer
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
No concurrent adrenal steroids, androgens, other progestational agents, or appetite stimulants (e.g., dronabinol)
Radiotherapy:
Surgery:
Other:
Study Chair: | Aminah Jatoi, MD | Mayo Clinic |
Study Chair: | Neil MacDonald, MD, FRCPC | McGill Cancer Centre at McGill University |
Study ID Numbers: | CDR0000069218, NCCTG-989255, CAN-NCIC-SC18, NCI-P02-0205 |
Study First Received: | March 8, 2002 |
Last Updated: | October 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00031707 |
Health Authority: | United States: Federal Government |
anorexia cachexia |
Body Weight Weight Loss Anorexia |
Cachexia Megestrol Megestrol Acetate |
Antineoplastic Agents, Hormonal Antineoplastic Agents Contraceptive Agents Physiological Effects of Drugs Contraceptives, Oral Contraceptive Agents, Female Central Nervous System Stimulants |
Reproductive Control Agents Pharmacologic Actions Therapeutic Uses Contraceptives, Oral, Synthetic Central Nervous System Agents Appetite Stimulants |