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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
This study has been completed.
Sponsors and Collaborators: North Central Cancer Treatment Group
National Cancer Institute (NCI)
National Cancer Institute of Canada
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00031707
  Purpose

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 Intervention Phase
Cancer-Related Problem/Condition
Drug: megestrol acetate
Drug: omega-3 fatty acids
Phase III

MedlinePlus related topics: Cancer Dietary Supplements Weight Control
Drug Information available for: Megestrol acetate Megestrol
U.S. FDA Resources
Study Type: Interventional
Study Design: Supportive Care, Randomized, Open Label, Active Control
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

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: March 2000
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.

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00031707

  Show 44 Study Locations
Sponsors and Collaborators
North Central Cancer Treatment Group
National Cancer Institute of Canada
Investigators
Study Chair: Aminah Jatoi, MD Mayo Clinic
Study Chair: Neil MacDonald, MD, FRCPC McGill Cancer Centre at McGill University
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications of Results:
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 patients with cancer-associated wasting: a North Central Cancer Treatment Group and National Cancer Institute of Canada collaborative effort. J Clin Oncol. 2004 Jun 15;22(12):2469-76.
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.

Study ID Numbers: CDR0000069218, NCCTG-989255, CAN-NCIC-SC18, NCI-P02-0205
Study First Received: March 8, 2002
Last Updated: October 18, 2008
ClinicalTrials.gov Identifier: NCT00031707  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
anorexia
cachexia

Study placed in the following topic categories:
Body Weight
Weight Loss
Anorexia
Cachexia
Megestrol
Megestrol Acetate

Additional relevant MeSH terms:
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Contraceptive Agents
Physiological Effects of Drugs
Contraceptives, Oral
Contraceptive Agents, Female
Central Nervous System Stimulants
Reproductive Control Agents
Pharmacologic Actions
Therapeutic Uses
Contraceptives, Oral, Synthetic
Central Nervous System Agents
Appetite Stimulants

ClinicalTrials.gov processed this record on January 15, 2009