Comparison of Megestrol and/or Omega-3 Fatty Acid-Enriched Nutritional Supplement in Treating Patients With Cancer-Related Weight Loss and Lack of Appetite
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Anorexia; Cachexia
Intervention: megestrol acetate (Drug); omega-3 fatty acids (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: North Central Cancer Treatment Group Official(s) and/or principal investigator(s):
Aminah Jatoi, MD, Study Chair, Affiliation: Mayo Clinic
Neil MacDonald, MD, FRCPC, Study Chair, Affiliation: McGill Cancer Centre at McGill University
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.
Clinical Details
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 design: Supportive Care, Randomized, Open Label, Active Control
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.
- 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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
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
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
Locations and Contacts
Cross Cancer Institute, Edmonton, Alberta T6G 1Z2, Canada
Tom Baker Cancer Center - Calgary, Calgary, Alberta T2N 4N2, Canada
CCOP - Scottsdale Oncology Program, Scottsdale, Arizona 85259-5404, United States
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
Nanaimo Cancer Clinic, Nanaimo, British Columbia V9S 2B7, Canada
Mayo Clinic, Jacksonville, Florida 32224, United States
CCOP - Carle Cancer Center, Urbana, Illinois 61801, United States
CCOP - Illinois Oncology Research Association, Peoria, Illinois 61602, United States
CCOP - Cedar Rapids Oncology Project, Cedar Rapids, Iowa 52403-1206, United States
CCOP - Iowa Oncology Research Association, Des Moines, Iowa 50309-1016, United States
Siouxland Hematology-Oncology, Sioux City, Iowa 51101-1733, United States
CCOP - Wichita, Wichita, Kansas 67214-3882, United States
CCOP - Ochsner, New Orleans, Louisiana 70121, United States
CancerCare Manitoba, Winnipeg, Manitoba R3E 0V9, Canada
CCOP - Ann Arbor Regional, Ann Arbor, Michigan 48106, United States
CCOP - Duluth, Duluth, Minnesota 55805, United States
CentraCare Health Plaza, Saint Cloud, Minnesota 56303, United States
Mayo Clinic Cancer Center, Rochester, Minnesota 55905, United States
CCOP - Missouri Valley Cancer Consortium, Omaha, Nebraska 68106, United States
Saint John Regional Hospital, Saint John, New Brunswick E2L 4L2, Canada
Newfoundland Cancer Treatment and Research Foundation, St. Johns, Newfoundland and Labrador A1B 3V6, Canada
Altru Health Systems, Grand Forks, North Dakota 58201, United States
CCOP - Merit Care Hospital, Fargo, North Dakota 58122, United States
Medcenter One Health System, Bismarck, North Dakota 58501, United States
CCOP - Toledo Community Hospital Oncology Program, Toledo, Ohio 43623-3456, United States
Cancer Care Ontario-Hamilton Regional Cancer Centre, Hamilton, Ontario L8V 5C2, Canada
Cancer Care Ontario-London Regional Cancer Centre, London, Ontario N6A 4L6, Canada
Kingston Regional Cancer Centre, Kingston, Ontario K7L 5P9, Canada
Ottawa Regional Cancer Centre, Ottawa, Ontario K1H 1C4, Canada
Peterborough Oncology Clinic, Peterborough, Ontario K9H 7B6, Canada
Toronto General Hospital, Toronto, Ontario M5G 2C4, Canada
Toronto Sunnybrook Regional Cancer Centre, Toronto, Ontario M4N 3M5, Canada
Trillium Health Centre, Mississauga, Ontario L5B 1B8, Canada
William Osler Health Centre, Brampton, Ontario L6W 2Z8, Canada
Allegheny General Hospital, Pittsburgh, Pennsylvania 15212-4772, United States
CCOP - Geisinger Clinic and Medical Center, Danville, Pennsylvania 17822-2001, United States
Queen Elizabeth Hospital, PEI, Charlottetown, Prince Edward Island C1A 8T5, Canada
L'Hopital Laval, Ste-Foy, Quebec G1V 4G5, Canada
Maisonneuve-Rosemont Hospital, Montreal, Quebec H1T 2M4, Canada
McGill University, Montreal, Quebec H2W 1S6, Canada
Allan Blair Cancer Centre, Regina, Saskatchewan S4T 7T1, Canada
CCOP - Sioux Community Cancer Consortium, Sioux Falls, South Dakota 57104, United States
Rapid City Regional Hospital, Rapid City, South Dakota 57709, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: March 2000
Last updated: May 23, 2008
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