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
18 Years
N/A
Both
Anorexia, Cachexia
Trial Information
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
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Open Label, Primary Purpose: Supportive Care
Principal Investigator
Aminah Jatoi, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Mayo Clinic
Authority:
United States: Federal Government
Study ID:
CDR0000069218
NCT ID:
NCT00031707
Start Date:
March 2000
Completion Date:
Related Keywords:
- Anorexia
- Cachexia
- anorexia
- cachexia
- Anorexia
- Cachexia
Name | Location |
|---|---|
| Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
| CCOP - Ann Arbor Regional | Ann Arbor, Michigan 48106 |
| CCOP - Wichita | Wichita, Kansas 67214-3882 |
| CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
| CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
| CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
| CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
| CCOP - Duluth | Duluth, Minnesota 55805 |
| CCOP - Scottsdale Oncology Program | Scottsdale, Arizona 85259-5404 |
| CCOP - Cedar Rapids Oncology Project | Cedar Rapids, Iowa 52403-1206 |
| Siouxland Hematology-Oncology | Sioux City, Iowa 51101-1733 |
| CCOP - Ochsner | New Orleans, Louisiana 70121 |
| CCOP - Merit Care Hospital | Fargo, North Dakota 58122 |
| Altru Health Systems | Grand Forks, North Dakota 58201 |
| CCOP - Toledo Community Hospital Oncology Program | Toledo, Ohio 43623-3456 |
| Rapid City Regional Hospital | Rapid City, South Dakota 57709 |
| CCOP - Sioux Community Cancer Consortium | Sioux Falls, South Dakota 57105-1080 |
| CCOP - Geisinger Clinic and Medical Center | Danville, Pennsylvania 17822-2001 |
| Allegheny General Hospital | Pittsburgh, Pennsylvania 15212-4772 |
| Mayo Clinic | Jacksonville, Florida 32224 |
| Medcenter One Health System | Bismarck, North Dakota 58501 |
| CentraCare Health Plaza | Saint Cloud, Minnesota 56303 |
