Comparison of Megestrol and/or Omega-3 Fatty Acid-Enriched Nutritional Supplement in Treating Patients With Cancer-Related Weight Loss and Lack of Appetite

• Status: Completed
• Trial end date: 2004-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alliance for Clinical Trials in Oncology
• Collaborators: National Cancer Institute (NCI); NCIC Clinical Trials Group
• Treatments: Megestrol; Megestrol Acetate

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically proven cancer other than brain, breast, ovarian, endometrial, or prostate cancer

• Compelling clinical evidence of cancer is allowed when tissue sample is unobtainable

• Considered incurable with available therapies

• At least 5 pounds weight loss within the past 2 months (excluding perioperative weight loss) and/or have estimated caloric intake of less than 20 cal/kg daily

• Weight loss must be perceived as a problem by the patient

• Potential weight gain must be considered beneficial by the attending physician

• No history of primary brain cancer or brain metastases

• No clinical evidence of ascites

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• At least 3 months

Cardiovascular:

• No poorly controlled congestive heart failure

• No poorly controlled hypertension

• No history of thromboembolic disease

Other:

• Not pregnant or nursing

• Fertile patients must use effective contraception

• Alert and mentally competent

• Able to reliably take oral medication

• No known mechanical obstruction of the alimentary tract, malabsorption, or intractable vomiting (more than 5 episodes per week)

• No diabetes requiring insulin

• Diabetes requiring an oral hypoglycemic agent or diet control allowed

PRIOR CONCURRENT THERAPY:

Chemotherapy:

• Concurrent chemotherapy allowed

Endocrine therapy:

• At least 1 month since prior adrenal steroids, androgens, progestational agents, or appetite stimulants (e.g., dronabinol)

• No concurrent adrenal steroids, androgens, other progestational agents, or appetite stimulants (e.g., dronabinol)

• Inhalant, topical, or optical steroids allowed

• Short-term dexamethasone as an anti-emetic during chemotherapy allowed

Radiotherapy:

• Concurrent radiotherapy allowed

Other:

• No tube feedings or parenteral nutrition