Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Supportive care	Completed	18 and over	NCI	NCCTG-989255 CAN-NCIC-SC18, NCI-P02-0205, NCT00031707, SC18

Objectives

1. 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.
2. Determine the effect of these regimens on nausea and vomiting in these patients.
3. Assess quality of life in patients treated with these regimens.
4. Determine the toxic effects of these regimens in these patients.
5. Compare overall survival of patients treated with these regimens.
6. Correlate interleukin-6 concentration changes with appetite and weight changes in patients treated with these regimens.

Entry 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

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

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

Expected Enrollment

A total of 450 patients (150 per treatment arm) will be accrued for this study within 15 months.

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.

• Arm I: Patients receive oral megestrol once daily and oral placebo twice daily.
• Arm II: Patients receive oral placebo once daily and an eicosapentaenoic acid (EPA)-enriched nutritional supplement twice daily.
• Arm III: 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.

Jatoi A, Rowland K, Loprinzi CL, et al.: An eicosapentaenoic acid supplement versus megestrol acetate versus both for patients with cancer-associated wasting: a North Central Cancer Treatment Group and National Cancer Institute of Canada collaborative effort. J Clin Oncol 22 (12): 2469-76, 2004.[PUBMED Abstract]

Jatoi A, Rowland KM, Loprinzi CL, et al.: An eicosapentainoic acid (EPA)-enriched supplement versus megestrol acetate (MA) versus both for patients with cancer-associated wasting. A collaborative effort from the North Central Cancer Treatment Group (NCCTG) and the National Cancer Institute of Canada. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-2987, 743, 2003.

Trial Contact Information

Trial Lead Organizations

North Central Cancer Treatment Group

Aminah Jatoi, MD, Protocol chair		Ph: 507-284-4918

NCIC-Clinical Trials Group

Neil MacDonald, MD, FRCPC, Protocol chair		Ph: 514-398-8988 Email: neil.macdonald@mcgill.ca

Registry Information
Official Title		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
Trial Start Date		2000-03-31
Registered in ClinicalTrials.gov		NCT00031707
Date Submitted to PDQ		2002-01-09
Information Last Verified		2007-11-23
NCI Grant/Contract Number		CA31946

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