Spots Global Cancer Trial Database for Comparison of Megestrol and/or Omega-3 Fatty Acid-Enriched Nutritional Supplement in Treating Patients With Cancer-Related Weight Loss and Lack of Appetite
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Trial Identification
Brief 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
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
Study ID: NCT00031707
Study Description
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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
CCOP - Scottsdale Oncology Program, Scottsdale, Arizona, United States
Mayo Clinic, Jacksonville, Florida, United States
CCOP - Illinois Oncology Research Association, Peoria, Illinois, United States
CCOP - Carle Cancer Center, Urbana, Illinois, United States
CCOP - Cedar Rapids Oncology Project, Cedar Rapids, Iowa, United States
CCOP - Iowa Oncology Research Association, Des Moines, Iowa, United States
Siouxland Hematology-Oncology, Sioux City, Iowa, United States
CCOP - Wichita, Wichita, Kansas, United States
CCOP - Ochsner, New Orleans, Louisiana, United States
CCOP - Ann Arbor Regional, Ann Arbor, Michigan, United States
CCOP - Duluth, Duluth, Minnesota, United States
Mayo Clinic Cancer Center, Rochester, Minnesota, United States
CentraCare Health Plaza, Saint Cloud, Minnesota, United States
CCOP - Missouri Valley Cancer Consortium, Omaha, Nebraska, United States
Medcenter One Health System, Bismarck, North Dakota, United States
CCOP - Merit Care Hospital, Fargo, North Dakota, United States
Altru Health Systems, Grand Forks, North Dakota, United States
CCOP - Toledo Community Hospital Oncology Program, Toledo, Ohio, United States
CCOP - Geisinger Clinic and Medical Center, Danville, Pennsylvania, United States
Allegheny General Hospital, Pittsburgh, Pennsylvania, United States
Rapid City Regional Hospital, Rapid City, South Dakota, United States
CCOP - Sioux Community Cancer Consortium, Sioux Falls, South Dakota, United States
Tom Baker Cancer Center - Calgary, Calgary, Alberta, Canada
Cross Cancer Institute, Edmonton, Alberta, Canada
British Columbia Cancer Agency - Centre for the Southern Interior, Kelowna, British Columbia, Canada
Nanaimo Cancer Clinic, Nanaimo, British Columbia, Canada
British Columbia Cancer Agency, Vancouver, British Columbia, Canada
CancerCare Manitoba, Winnipeg, Manitoba, Canada
Saint John Regional Hospital, Saint John, New Brunswick, Canada
Newfoundland Cancer Treatment and Research Foundation, St. Johns, Newfoundland and Labrador, Canada
William Osler Health Centre, Brampton, Ontario, Canada
Cancer Care Ontario-Hamilton Regional Cancer Centre, Hamilton, Ontario, Canada
Kingston Regional Cancer Centre, Kingston, Ontario, Canada
Cancer Care Ontario-London Regional Cancer Centre, London, Ontario, Canada
Trillium Health Centre, Mississauga, Ontario, Canada
Ottawa Regional Cancer Centre, Ottawa, Ontario, Canada
Peterborough Oncology Clinic, Peterborough, Ontario, Canada
Toronto Sunnybrook Regional Cancer Centre, Toronto, Ontario, Canada
Toronto General Hospital, Toronto, Ontario, Canada
Queen Elizabeth Hospital, PEI, Charlottetown, Prince Edward Island, Canada
Maisonneuve-Rosemont Hospital, Montreal, Quebec, Canada
McGill University, Montreal, Quebec, Canada
L'Hopital Laval, Ste-Foy, Quebec, Canada
Allan Blair Cancer Centre, Regina, Saskatchewan, Canada
Contact Details
Name: Aminah Jatoi, MD
Affiliation: Mayo Clinic
Role: STUDY_CHAIR
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