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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Anorexia, Cachexia

Thank you

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 CenterRochester, Minnesota  55905
CCOP - Ann Arbor RegionalAnn Arbor, Michigan  48106
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - DuluthDuluth, Minnesota  55805
CCOP - Scottsdale Oncology ProgramScottsdale, Arizona  85259-5404
CCOP - Cedar Rapids Oncology ProjectCedar Rapids, Iowa  52403-1206
Siouxland Hematology-OncologySioux City, Iowa  51101-1733
CCOP - OchsnerNew Orleans, Louisiana  70121
CCOP - Merit Care HospitalFargo, North Dakota  58122
Altru Health SystemsGrand Forks, North Dakota  58201
CCOP - Toledo Community Hospital Oncology ProgramToledo, Ohio  43623-3456
Rapid City Regional HospitalRapid City, South Dakota  57709
CCOP - Sioux Community Cancer ConsortiumSioux Falls, South Dakota  57105-1080
CCOP - Geisinger Clinic and Medical CenterDanville, Pennsylvania  17822-2001
Allegheny General HospitalPittsburgh, Pennsylvania  15212-4772
Mayo ClinicJacksonville, Florida  32224
Medcenter One Health SystemBismarck, North Dakota  58501
CentraCare Health PlazaSaint Cloud, Minnesota  56303