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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00031707
Recruitment Status : Completed
First Posted : August 5, 2003
Last Update Posted : July 14, 2016
Sponsor:
Collaborators:
National Cancer Institute (NCI)
NCIC Clinical Trials Group
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Tracking Information
First Submitted Date  ICMJE March 8, 2002
First Posted Date  ICMJE August 5, 2003
Last Update Posted Date July 14, 2016
Study Start Date  ICMJE March 2000
Actual Primary Completion Date January 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 7, 2015)
Compare the appetite-stimulating properties (eg, patient weight, rate of weight change, and appetite) [ Time Frame: Up to 5 years ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 7, 2015)
  • Assess quality of life [ Time Frame: Up to 5 years ]
  • Overall survival [ Time Frame: Up to 5 years ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Megestrol and/or Omega-3 Fatty Acid-Enriched Nutritional Supplement in Treating Patients With Cancer-Related Weight Loss and Lack of Appetite
Official Title  ICMJE 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
Brief 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.

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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Anorexia
  • Cachexia
Intervention  ICMJE
  • Dietary Supplement: eicosapentaenoic acid
  • Drug: megestrol acetate
  • Other: placebo
Study Arms  ICMJE
  • 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.

    Interventions:
    • Drug: megestrol acetate
    • Other: placebo
  • 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.

    Interventions:
    • Dietary Supplement: eicosapentaenoic acid
    • Other: placebo
  • 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.

    Interventions:
    • Dietary Supplement: eicosapentaenoic acid
    • Drug: megestrol acetate
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 7, 2015)
429
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE January 2004
Actual Primary Completion Date January 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00031707
Other Study ID Numbers  ICMJE NCCTG-989255
CDR0000069218 ( Registry Identifier: PDQ (Physician Data Query) )
CAN-NCIC-SC18
NCI-P02-0205
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alliance for Clinical Trials in Oncology
Study Sponsor  ICMJE Alliance for Clinical Trials in Oncology
Collaborators  ICMJE
  • National Cancer Institute (NCI)
  • NCIC Clinical Trials Group
Investigators  ICMJE
Study Chair: Aminah Jatoi, MD Mayo Clinic
PRS Account Alliance for Clinical Trials in Oncology
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP