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

OBJECTIVES:

- Compare the appetite-stimulating properties of megestrol vs an eicosapentaenoic
acid-enriched nutritional supplement vs both, in terms of patient weight, rate of
weight change, and appetite, in patients with cancer-related cachexia and anorexia.

- Determine the effect of these regimens on nausea and vomiting in these patients.

- Assess quality of life in patients treated with these regimens.

- Determine the toxic effects of these regimens in these patients.

- Compare overall survival of patients treated with these regimens.

- Correlate interleukin-6 concentration changes with appetite and weight changes in
patients treated with these regimens.

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.

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