Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.


Condition or disease Intervention/treatment Phase
Anorexia Cachexia Dietary Supplement: eicosapentaenoic acid Drug: megestrol acetate Other: placebo Phase 3

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 429 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
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
Study Start Date : March 2000
Actual Primary Completion Date : January 2004
Actual Study Completion Date : January 2004

Resource links provided by the National Library of Medicine


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.

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.

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.

Dietary Supplement: eicosapentaenoic acid
Drug: megestrol acetate



Primary Outcome Measures :
  1. Compare the appetite-stimulating properties (eg, patient weight, rate of weight change, and appetite) [ Time Frame: Up to 5 years ]

Secondary Outcome Measures :
  1. Assess quality of life [ Time Frame: Up to 5 years ]
  2. Overall survival [ Time Frame: Up to 5 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00031707


Locations
Show Show 44 study locations
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
NCIC Clinical Trials Group
Investigators
Layout table for investigator information
Study Chair: Aminah Jatoi, MD Mayo Clinic

Publications of Results:
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) and the National Cancer Institute of Canada. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-2987, 743, 2003.

Layout table for additonal information
Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00031707    
Other Study ID Numbers: NCCTG-989255
CDR0000069218 ( Registry Identifier: PDQ (Physician Data Query) )
CAN-NCIC-SC18
NCI-P02-0205
First Posted: August 5, 2003    Key Record Dates
Last Update Posted: July 14, 2016
Last Verified: July 2016
Keywords provided by Alliance for Clinical Trials in Oncology:
anorexia
cachexia
Additional relevant MeSH terms:
Layout table for MeSH terms
Wasting Syndrome
Anorexia
Cachexia
Signs and Symptoms, Digestive
Signs and Symptoms
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Metabolic Diseases
Nutrition Disorders
Megestrol
Megestrol Acetate
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Appetite Stimulants
Central Nervous System Stimulants