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

Inclusion 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

Hematopoietic:

- Not specified

Hepatic:

- Not specified

Renal:

- Not specified

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:

Biologic therapy:

- Not specified

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

Surgery:

- Not specified

Other:

- No tube feedings or parenteral nutrition