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

Alliance for Clinical Trials in Oncology

Status and phase: Completed; Phase 3

Conditions: Anorexia; Cachexia

Treatments: Drug: megestrol acetate; Other: placebo; Dietary Supplement: eicosapentaenoic acid

Study type: Interventional

Funder types: Other; NETWORK; NIH

Identifiers

NCT00031707

NCI-P02-0205

CAN-NCIC-SC18

NCCTG-989255

CDR0000069218 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 429 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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429 participants in 3 patient groups

megestrol + placebo

Active Comparator group

Description:

Patients receive oral megestrol once daily and oral placebo twice daily. 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.

Treatment:

Other: placebo

Drug: megestrol acetate

eicosapentaenoic acid + placebo

Active Comparator group

Description:

Patients receive oral placebo once daily and an eicosapentaenoic acid (EPA)-enriched nutritional supplement twice daily. 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.

Treatment:

Other: placebo

Dietary Supplement: eicosapentaenoic acid

megestrol + eicosapentaenoic acid

Experimental group

Description:

Patients receive oral megestrol once daily and an EPA-enriched nutritional supplement twice daily. 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.

Treatment:

Dietary Supplement: eicosapentaenoic acid

Drug: megestrol acetate