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Comparison of Megestrol and/or Omega-3 Fatty Acid-Enriched Nutritional Supplement in Treating Patients With Cancer-Related Weight Loss and Lack of Appetite Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on 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. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Comparison of Megestrol and/or Omega-3 Fatty Acid-Enriched Nutritional Supplement in Treating Patients With Cancer-Related Weight Loss and Lack of Appetite Clinical research trials and Comparison of Megestrol and/or Omega-3 Fatty Acid-Enriched Nutritional Supplement in Treating Patients With Cancer-Related Weight Loss and Lack of Appetite healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Comparison of Megestrol and/or Omega-3 Fatty Acid-Enriched Nutritional Supplement in Treating Patients With Cancer-Related Weight Loss and Lack of Appetite. Comparison of Megestrol and/or Omega-3 Fatty Acid-Enriched Nutritional Supplement in Treating Patients With Cancer-Related Weight Loss and Lack of Appetite Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Comparison of Megestrol and/or Omega-3 Fatty Acid-Enriched Nutritional Supplement in Treating Patients With Cancer-Related Weight Loss and Lack of Appetite clinical trial. Test subjects typically receive the most effective healthcare possible for their Comparison of Megestrol and/or Omega-3 Fatty Acid-Enriched Nutritional Supplement in Treating Patients With Cancer-Related Weight Loss and Lack of Appetite condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Comparison of Megestrol and/or Omega-3 Fatty Acid-Enriched Nutritional Supplement in Treating Patients With Cancer-Related Weight Loss and Lack of Appetite  Comparison of Megestrol and/or Omega-3 Fatty Acid-Enriched Nutritional Supplement in Treating Patients With Cancer-Related Weight Loss and Lack of Appetite
Comparison of Megestrol and/or Omega-3 Fatty Acid-Enriched Nutritional Supplement in Treating Patients With Cancer-Related Weight Loss and Lack of Appetite
For Condition: Anorexia,Cachexia
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , National Cancer Institute of Canada,North Central Cancer Treatment Group
Synopsis: 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.
Details: OBJECTIVES: I. 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. II. Determine the effect of these regimens on nausea and vomiting in these patients. III. Assess quality of life in patients treated with these regimens. IV. Determine the toxic effects of these regimens in these patients. V. Compare overall survival of patients treated with these regimens. VI. Correlate interleukin-6 concentration changes with appetite and weight changes in patients treated with these regimens. PROTOCOL 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. PROJECTED ACCRUAL: A total of 450 patients (150 per treatment arm) will be accrued for this study within 15 months.
Eligibility:
Study Type: Interventional, Educational/Counseling/Training
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AminahJatoi, Study Chair, North Central Cancer Treatment Group
Cancer Care Ontario-Hamilton Regional Cancer Centre
Hamilton, Ontario, L8V 5C2
Canada
William Osler Health Centre
Brampton, Ontario, L6W 2Z8
Canada
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, 48106
United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, 68106
United States
Nanaimo Cancer Clinic
Nanaimo, British Columbia, V9S 2B7
Canada
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, N6A 4L6
Canada
British Columbia Cancer Agency
Vancouver, British Columbia, V5Z 4E6
Canada
British Columbia Cancer Agency - Centre for the Southern Interior
Kelowna, British Columbia, V1Y 5L3
Canada
Maisonneuve-Rosemont Hospital
Montreal, Quebec, H1T 2M4
Canada
CentraCare Health Plaza
St. Cloud, Minnesota, 56303
United States
Medcenter One Health System
Bismark, North Dakota, 58501
United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, 52403-1206
United States
Newfoundland Cancer Treatment and Research Foundation
St. Johns, Newfoundland and Labrador, A1B 3V6
Canada
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, 17822-2001
United States
CCOP - Toledo Community Hospital Oncology Program
Toledo, Ohio, 43623-3456
United States
Trillium Health Centre
Mississauga, Ontario, L5B 1B8
Canada
CCOP - Ochsner
New Orleans, Louisiana, 70121
United States
CCOP - Carle Cancer Center
Urbana, Illinois, 61801
United States
Queen Elizabeth Hospital, PEI
Charlottetown, Prince Edward Island, C1A 8T5
Canada
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212-4772
United States
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, M4N 3M5
Canada
Siouxland Hematology-Oncology
Sioux City, Iowa, 51101-1733
United States
CCOP - Duluth
Duluth, Minnesota, 55805
United States
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Canada
Saint John Regional Hospital
Saint John, New Brunswick, E2L 4L2
Canada
CCOP - Wichita
Wichita, Kansas, 67214-3882
United States
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1
Canada
Ottawa Regional Cancer Centre
Ottawa, Ontario, K1H 1C4
Canada
L'Hopital Laval
Ste Foy, Quebec, G1V 4G5
Canada
Rapid City Regional Hospital
Rapid City, South Dakota, 57709
United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
Mayo Clinic
Jacksonville, Florida, 32224
United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309-1016
United States
Altru Health Systems
Grand Forks, North Dakota, 58201
United States
Tom Baker Cancer Center - Calgary
Calgary, Alberta, T2N 4N2
Canada
Toronto General Hospital
Toronto, Ontario, M5G 2C4
Canada
Peterborough Oncology Clinic
Peterborough, Ontario, K9H 7B6
Canada
CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, 85259-5404
United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, 61602
United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, 57104
United States
McGill University
Montreal, Quebec, H2W 1S6
Canada
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9
Canada
Kingston Regional Cancer Centre
Kingston, Ontario, K7L 5P9
Canada
CCOP - Merit Care Hospital
Fargo, North Dakota, 58122
United States
Additional Information:
Study ID Numbers: CDR0000069218; NCI-P02-0205,NCCTG-989255
Study Start Date: March 2000
Record last reviewed: August 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00031707
Other Anorexia Studies:
1. Comparison of Megestrol and/or Omega-3 Fatty Acid-Enriched Nutritional Supplement in Treating Patients With Cancer-Related Weight Loss and Lack of Appetite
2. Etanercept in Treating Cancer-Related Cachexia and Anorexia in Patients With Advanced Cancer
3. A Study of Different Doses of Megestrol Acetate in Patients with AIDS Who Have Anorexia and Malnutrition
4. Creatine in Treating Patients With Cancer-Associated Weight Loss
5. Megestrol in Treating Patients Who Are Undergoing Radiation Therapy for Lung Cancer
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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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