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

July 12, 2016 updated by: Alliance for Clinical Trials in Oncology

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

429

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Tom Baker Cancer Center - Calgary
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 5L3
        • British Columbia Cancer Agency - Centre for the Southern Interior
      • Nanaimo, British Columbia, Canada, V9S 2B7
        • Nanaimo Cancer Clinic
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • British Columbia Cancer Agency
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • CancerCare Manitoba
    • New Brunswick
      • Saint John, New Brunswick, Canada, E2L 4L2
        • Saint John Regional Hospital
    • Newfoundland and Labrador
      • St. Johns, Newfoundland and Labrador, Canada, A1B 3V6
        • Newfoundland Cancer Treatment and Research Foundation
    • Ontario
      • Brampton, Ontario, Canada, L6W 2Z8
        • William Osler Health Centre
      • Hamilton, Ontario, Canada, L8V 5C2
        • Cancer Care Ontario-Hamilton Regional Cancer Centre
      • Kingston, Ontario, Canada, K7L 5P9
        • Kingston Regional Cancer Centre
      • London, Ontario, Canada, N6A 4L6
        • Cancer Care Ontario-London Regional Cancer Centre
      • Mississauga, Ontario, Canada, L5B 1B8
        • Trillium Health Centre
      • Ottawa, Ontario, Canada, K1H 1C4
        • Ottawa Regional Cancer Centre
      • Peterborough, Ontario, Canada, K9H 7B6
        • Peterborough Oncology Clinic
      • Toronto, Ontario, Canada, M5G 2C4
        • Toronto General Hospital
      • Toronto, Ontario, Canada, M4N 3M5
        • Toronto Sunnybrook Regional Cancer Centre
    • Prince Edward Island
      • Charlottetown, Prince Edward Island, Canada, C1A 8T5
        • Queen Elizabeth Hospital, PEI
    • Quebec
      • Montreal, Quebec, Canada, H2W 1S6
        • McGill University
      • Montreal, Quebec, Canada, H1T 2M4
        • Maisonneuve-Rosemont Hospital
      • Ste-Foy, Quebec, Canada, G1V 4G5
        • L'Hopital Laval
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4T 7T1
        • Allan Blair Cancer Centre
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259-5404
        • CCOP - Scottsdale Oncology Program
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic
    • Illinois
      • Peoria, Illinois, United States, 61602
        • CCOP - Illinois Oncology Research Association
      • Urbana, Illinois, United States, 61801
        • CCOP - Carle Cancer Center
    • Iowa
      • Cedar Rapids, Iowa, United States, 52403-1206
        • CCOP - Cedar Rapids Oncology Project
      • Des Moines, Iowa, United States, 50309-1016
        • CCOP - Iowa Oncology Research Association
      • Sioux City, Iowa, United States, 51101-1733
        • Siouxland Hematology-Oncology
    • Kansas
      • Wichita, Kansas, United States, 67214-3882
        • CCOP - Wichita
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • CCOP - Ochsner
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
        • CCOP - Ann Arbor Regional
    • Minnesota
      • Duluth, Minnesota, United States, 55805
        • CCOP - Duluth
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Cancer Center
      • Saint Cloud, Minnesota, United States, 56303
        • CentraCare Health Plaza
    • Nebraska
      • Omaha, Nebraska, United States, 68106
        • CCOP - Missouri Valley Cancer Consortium
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
        • Medcenter One Health System
      • Fargo, North Dakota, United States, 58122
        • CCOP - Merit Care Hospital
      • Grand Forks, North Dakota, United States, 58201
        • Altru Health Systems
    • Ohio
      • Toledo, Ohio, United States, 43623-3456
        • CCOP - Toledo Community Hospital Oncology Program
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822-2001
        • CCOP - Geisinger Clinic and Medical Center
      • Pittsburgh, Pennsylvania, United States, 15212-4772
        • Allegheny General Hospital
    • South Dakota
      • Rapid City, South Dakota, United States, 57709
        • Rapid City Regional Hospital
      • Sioux Falls, South Dakota, United States, 57104
        • CCOP - Sioux Community Cancer Consortium

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Other: placebo
Drug: megestrol acetate
Active Comparator: 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.
Other: placebo
Dietary supplement: eicosapentaenoic acid
Experimental: 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.
Drug: megestrol acetate
Dietary supplement: eicosapentaenoic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Compare the appetite-stimulating properties (eg, patient weight, rate of weight change, and appetite)
Time Frame: Up to 5 years
Up to 5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: Up to 5 years
Up to 5 years
Assess quality of life
Time Frame: Up to 5 years
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alliance for Clinical Trials in Oncology

Collaborators

National Cancer Institute (NCI)
NCIC Clinical Trials Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2000

Primary Completion (Actual)

January 1, 2004

Study Completion (Actual)

January 1, 2004

Study Registration Dates

First Submitted

March 8, 2002

First Submitted That Met QC Criteria

August 4, 2003

First Posted (Estimate)

August 5, 2003

Study Record Updates

Last Update Posted (Estimate)

July 14, 2016

Last Update Submitted That Met QC Criteria

July 12, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCCTG-989255
  • CDR0000069218 (Registry Identifier: PDQ (Physician Data Query))
  • CAN-NCIC-SC18
  • NCI-P02-0205

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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