Comparison of Megestrol and/or Omega-3 Fatty Acid-Enriched Nutritional Supplement in Treating Patients With Cancer-Related Weight Loss and Lack of Appetite
Anorexia, Cachexia
About this trial
This is an interventional supportive care trial for Anorexia focused on measuring anorexia, cachexia
Eligibility 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
Sites / Locations
- CCOP - Scottsdale Oncology Program
- Mayo Clinic
- CCOP - Illinois Oncology Research Association
- CCOP - Carle Cancer Center
- CCOP - Cedar Rapids Oncology Project
- CCOP - Iowa Oncology Research Association
- Siouxland Hematology-Oncology
- CCOP - Wichita
- CCOP - Ochsner
- CCOP - Ann Arbor Regional
- CCOP - Duluth
- Mayo Clinic Cancer Center
- CentraCare Health Plaza
- CCOP - Missouri Valley Cancer Consortium
- Medcenter One Health System
- CCOP - Merit Care Hospital
- Altru Health Systems
- CCOP - Toledo Community Hospital Oncology Program
- CCOP - Geisinger Clinic and Medical Center
- Allegheny General Hospital
- Rapid City Regional Hospital
- CCOP - Sioux Community Cancer Consortium
- Tom Baker Cancer Center - Calgary
- Cross Cancer Institute
- British Columbia Cancer Agency - Centre for the Southern Interior
- Nanaimo Cancer Clinic
- British Columbia Cancer Agency
- CancerCare Manitoba
- Saint John Regional Hospital
- Newfoundland Cancer Treatment and Research Foundation
- William Osler Health Centre
- Cancer Care Ontario-Hamilton Regional Cancer Centre
- Kingston Regional Cancer Centre
- Cancer Care Ontario-London Regional Cancer Centre
- Trillium Health Centre
- Ottawa Regional Cancer Centre
- Peterborough Oncology Clinic
- Toronto Sunnybrook Regional Cancer Centre
- Toronto General Hospital
- Queen Elizabeth Hospital, PEI
- Maisonneuve-Rosemont Hospital
- McGill University
- L'Hopital Laval
- Allan Blair Cancer Centre
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Experimental
megestrol + placebo
eicosapentaenoic acid + placebo
megestrol + eicosapentaenoic acid
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.
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.
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.