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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Anorexia, Cachexia

Intervention / Treatment
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* Dietary Supplement: eicosapentaenoic acid
* Drug: megestrol acetate
* Other: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: megestrol + placebo<br>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. | Drug: megestrol acetate<br> <br> Other: placebo<br> <br> |
| Active Comparator: eicosapentaenoic acid + placebo<br>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. | Dietary Supplement: eicosapentaenoic acid<br> <br> Other: placebo<br> <br> |
| Experimental: megestrol + eicosapentaenoic acid<br>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. | Dietary Supplement: eicosapentaenoic acid<br> <br> Drug: megestrol acetate<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the appetite-stimulating properties (eg, patient weight, rate of weight change, and appetite) |  | Up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess quality of life |  | Up to 5 years | 
| Overall survival |  | Up to 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anorexia, cachexia