Comparison of Megestrol and/or Omega-3 Fatty Acid-Enriched Nutritional Supplement in Treating Patients With Cancer-Related Weight Loss and Lack of Appetite
- Conditions
- AnorexiaCachexia
- Interventions
- Registration Number
- NCT00031707
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 429
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description megestrol + placebo megestrol acetate 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. megestrol + placebo placebo 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. eicosapentaenoic acid + placebo eicosapentaenoic acid 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. eicosapentaenoic acid + placebo placebo 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. megestrol + eicosapentaenoic acid eicosapentaenoic acid 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. megestrol + eicosapentaenoic acid megestrol acetate 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.
- Primary Outcome Measures
Name Time Method Compare the appetite-stimulating properties (eg, patient weight, rate of weight change, and appetite) Up to 5 years
- Secondary Outcome Measures
Name Time Method Assess quality of life Up to 5 years Overall survival Up to 5 years
Trial Locations
- Locations (44)
Queen Elizabeth Hospital, PEI
π¨π¦Charlottetown, Prince Edward Island, Canada
Newfoundland Cancer Treatment and Research Foundation
π¨π¦St. Johns, Newfoundland and Labrador, Canada
Siouxland Hematology-Oncology
πΊπΈSioux City, Iowa, United States
CentraCare Health Plaza
πΊπΈSaint Cloud, Minnesota, United States
Medcenter One Health System
πΊπΈBismarck, North Dakota, United States
Altru Health Systems
πΊπΈGrand Forks, North Dakota, United States
CCOP - Geisinger Clinic and Medical Center
πΊπΈDanville, Pennsylvania, United States
Saint John Regional Hospital
π¨π¦Saint John, New Brunswick, Canada
Kingston Regional Cancer Centre
π¨π¦Kingston, Ontario, Canada
Trillium Health Centre
π¨π¦Mississauga, Ontario, Canada
Toronto Sunnybrook Regional Cancer Centre
π¨π¦Toronto, Ontario, Canada
Toronto General Hospital
π¨π¦Toronto, Ontario, Canada
Allan Blair Cancer Centre
π¨π¦Regina, Saskatchewan, Canada
CCOP - Merit Care Hospital
πΊπΈFargo, North Dakota, United States
CCOP - Iowa Oncology Research Association
πΊπΈDes Moines, Iowa, United States
Cross Cancer Institute
π¨π¦Edmonton, Alberta, Canada
CCOP - Ann Arbor Regional
πΊπΈAnn Arbor, Michigan, United States
CCOP - Cedar Rapids Oncology Project
πΊπΈCedar Rapids, Iowa, United States
Peterborough Oncology Clinic
π¨π¦Peterborough, Ontario, Canada
CCOP - Sioux Community Cancer Consortium
πΊπΈSioux Falls, South Dakota, United States
Rapid City Regional Hospital
πΊπΈRapid City, South Dakota, United States
Nanaimo Cancer Clinic
π¨π¦Nanaimo, British Columbia, Canada
McGill University
π¨π¦Montreal, Quebec, Canada
British Columbia Cancer Agency
π¨π¦Vancouver, British Columbia, Canada
Cancer Care Ontario-London Regional Cancer Centre
π¨π¦London, Ontario, Canada
William Osler Health Centre
π¨π¦Brampton, Ontario, Canada
CCOP - Wichita
πΊπΈWichita, Kansas, United States
Ottawa Regional Cancer Centre
π¨π¦Ottawa, Ontario, Canada
Maisonneuve-Rosemont Hospital
π¨π¦Montreal, Quebec, Canada
CCOP - Scottsdale Oncology Program
πΊπΈScottsdale, Arizona, United States
CCOP - Carle Cancer Center
πΊπΈUrbana, Illinois, United States
Mayo Clinic
πΊπΈJacksonville, Florida, United States
CCOP - Duluth
πΊπΈDuluth, Minnesota, United States
CCOP - Missouri Valley Cancer Consortium
πΊπΈOmaha, Nebraska, United States
Mayo Clinic Cancer Center
πΊπΈRochester, Minnesota, United States
Allegheny General Hospital
πΊπΈPittsburgh, Pennsylvania, United States
Tom Baker Cancer Center - Calgary
π¨π¦Calgary, Alberta, Canada
CCOP - Toledo Community Hospital Oncology Program
πΊπΈToledo, Ohio, United States
British Columbia Cancer Agency - Centre for the Southern Interior
π¨π¦Kelowna, British Columbia, Canada
Cancer Care Ontario-Hamilton Regional Cancer Centre
π¨π¦Hamilton, Ontario, Canada
L'Hopital Laval
π¨π¦Ste-Foy, Quebec, Canada
CCOP - Illinois Oncology Research Association
πΊπΈPeoria, Illinois, United States
CancerCare Manitoba
π¨π¦Winnipeg, Manitoba, Canada
CCOP - Ochsner
πΊπΈNew Orleans, Louisiana, United States