Comparison of Megestrol and/or Omega-3 Fatty Acid-Enriched Nutritional Supplement in Treating Patients With Cancer-Related Weight Loss and Lack of Appetite

Cachexia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00031707
• Other study ID #: NCCTG-989255
• Secondary ID: CDR0000069218CAN
• Status: Completed
• Phase: Phase 3
• First received: March 8, 2002
• Last updated: July 12, 2016
• Start date: March 2000
• Est. completion date: January 2004

Study information

• Verified date: July 2016
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 429
• Est. completion date: January 2004
• Est. primary completion date: January 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Anorexia
• Cachexia

Intervention

Dietary Supplement:
• eicosapentaenoic acid

Drug:
• megestrol acetate

Other:
• placebo

Locations

Country	Name	City	State
Canada	William Osler Health Centre	Brampton	Ontario
Canada	Tom Baker Cancer Center - Calgary	Calgary	Alberta
Canada	Queen Elizabeth Hospital, PEI	Charlottetown	Prince Edward Island
Canada	Cross Cancer Institute	Edmonton	Alberta
Canada	Cancer Care Ontario-Hamilton Regional Cancer Centre	Hamilton	Ontario
Canada	British Columbia Cancer Agency - Centre for the Southern Interior	Kelowna	British Columbia
Canada	Kingston Regional Cancer Centre	Kingston	Ontario
Canada	Cancer Care Ontario-London Regional Cancer Centre	London	Ontario
Canada	Trillium Health Centre	Mississauga	Ontario
Canada	Maisonneuve-Rosemont Hospital	Montreal	Quebec
Canada	McGill University	Montreal	Quebec
Canada	Nanaimo Cancer Clinic	Nanaimo	British Columbia
Canada	Ottawa Regional Cancer Centre	Ottawa	Ontario
Canada	Peterborough Oncology Clinic	Peterborough	Ontario
Canada	Allan Blair Cancer Centre	Regina	Saskatchewan
Canada	Saint John Regional Hospital	Saint John	New Brunswick
Canada	Newfoundland Cancer Treatment and Research Foundation	St. Johns	Newfoundland and Labrador
Canada	L'Hopital Laval	Ste-Foy	Quebec
Canada	Toronto General Hospital	Toronto	Ontario
Canada	Toronto Sunnybrook Regional Cancer Centre	Toronto	Ontario
Canada	British Columbia Cancer Agency	Vancouver	British Columbia
Canada	CancerCare Manitoba	Winnipeg	Manitoba
United States	CCOP - Ann Arbor Regional	Ann Arbor	Michigan
United States	Medcenter One Health System	Bismarck	North Dakota
United States	CCOP - Cedar Rapids Oncology Project	Cedar Rapids	Iowa
United States	CCOP - Geisinger Clinic and Medical Center	Danville	Pennsylvania
United States	CCOP - Iowa Oncology Research Association	Des Moines	Iowa
United States	CCOP - Duluth	Duluth	Minnesota
United States	CCOP - Merit Care Hospital	Fargo	North Dakota
United States	Altru Health Systems	Grand Forks	North Dakota
United States	Mayo Clinic	Jacksonville	Florida
United States	CCOP - Ochsner	New Orleans	Louisiana
United States	CCOP - Missouri Valley Cancer Consortium	Omaha	Nebraska
United States	CCOP - Illinois Oncology Research Association	Peoria	Illinois
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	Rapid City Regional Hospital	Rapid City	South Dakota
United States	Mayo Clinic Cancer Center	Rochester	Minnesota
United States	CentraCare Health Plaza	Saint Cloud	Minnesota
United States	CCOP - Scottsdale Oncology Program	Scottsdale	Arizona
United States	Siouxland Hematology-Oncology	Sioux City	Iowa
United States	CCOP - Sioux Community Cancer Consortium	Sioux Falls	South Dakota
United States	CCOP - Toledo Community Hospital Oncology Program	Toledo	Ohio
United States	CCOP - Carle Cancer Center	Urbana	Illinois
United States	CCOP - Wichita	Wichita	Kansas

Sponsors (3)

Lead Sponsor	Collaborator
Alliance for Clinical Trials in Oncology	National Cancer Institute (NCI), NCIC Clinical Trials Group

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (2)

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 pat — View Citation

Jatoi A, Rowland KM, Loprinzi CL, et al.: An eicosapentainoic acid (EPA)-enriched supplement versus megestrol acetate (MA) versus both for patients with cancer-associated wasting. A collaborative effort from the North Central Cancer Treatment Group (NCCTG

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare the appetite-stimulating properties (eg, patient weight, rate of weight change, and appetite)		Up to 5 years	No
Secondary	Assess quality of life		Up to 5 years	No
Secondary	Overall survival		Up to 5 years	No