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

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

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.

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