Comparison of Megestrol and/or Omega-3 Fatty Acid-Enriched Nutritional Supplement in Treating Patients With Cancer-Related Weight Loss and Lack of Appetite
NCT ID: NCT00031707
Last Updated: 2016-07-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
429 participants
INTERVENTIONAL
2000-03-31
2004-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Megestrol in Treating Patients Who Are Undergoing Radiation Therapy for Lung Cancer
NCT00031785
Megestrol to Limit Weight Loss and Improve Quality of Life in Treating Patients With Head and Neck Cancer
NCT00006799
Nano-crystalline Megestrol Acetate for Anorexia-Cachexia Syndrome in Advanced Lung Cancer
NCT07092137
Comparison of Nutritional Supplements in Preventing Weight Loss in Patients With Cancer
NCT00053053
A Pilot Study of Eicosapentaenoic Acid (EPA) in Patients With Cancer Cachexia
NCT00815685
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
megestrol + 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.
megestrol acetate
placebo
eicosapentaenoic acid + 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.
eicosapentaenoic acid
placebo
megestrol + 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.
eicosapentaenoic acid
megestrol acetate
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
eicosapentaenoic acid
megestrol acetate
placebo
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
NCIC Clinical Trials Group
NETWORK
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Aminah Jatoi, MD
Role: STUDY_CHAIR
Mayo Clinic
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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. John's, 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
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Jatoi A, Rowland K, Loprinzi CL, Sloan JA, Dakhil SR, MacDonald N, Gagnon B, Novotny PJ, Mailliard JA, Bushey TI, Nair S, Christensen B; North Central Cancer Treatment Group. An eicosapentaenoic acid supplement versus megestrol acetate versus both for patients with cancer-associated wasting: a North Central Cancer Treatment Group and National Cancer Institute of Canada collaborative effort. J Clin Oncol. 2004 Jun 15;22(12):2469-76. doi: 10.1200/JCO.2004.06.024.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CDR0000069218
Identifier Type: REGISTRY
Identifier Source: secondary_id
CAN-NCIC-SC18
Identifier Type: -
Identifier Source: secondary_id
NCI-P02-0205
Identifier Type: -
Identifier Source: secondary_id
NCCTG-989255
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.