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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase III Randomized Study of Megestrol Versus Eicosapentaenoic Acid-Enriched Nutritional Supplement Versus Both in Patients With Cancer-Related Cachexia and Anorexia

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Supportive care	Completed	18 and over	NCI	NCCTG-989255 CAN-NCIC-SC18, NCI-P02-0205, NCT00031707, SC18

Trial Description

Purpose:

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.

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.

Eligibility:

• At least 18 years old
• No brain cancer, breast cancer, ovarian cancer, endometrial cancer, or prostate cancer
• No brain metastases
• At least 1 month since hormone therapy
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will be randomly assigned to one of three groups. Patients in group one will receive megestrol by mouth once a day and a placebo by mouth twice a day. Patients in group two will receive a placebo by mouth once a day and an omega-3 fatty acid-enriched nutritional supplement twice a day. Patients in group three will receive megestrol by mouth once a day and an omega-3 fatty acid-enriched nutritional supplement twice a day. Treatment may continue for as long as benefit is shown. Quality of life will be assessed periodically. Patients will be evaluated every 6 months for 5 years.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

North Central Cancer Treatment Group

Aminah Jatoi, MD, Protocol chair		Ph: 507-284-4918

NCIC-Clinical Trials Group

Neil MacDonald, MD, FRCPC, Protocol chair		Ph: 514-398-8988 Email: neil.macdonald@mcgill.ca

Registry Information
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
Trial Start Date		2000-03-31
Registered in ClinicalTrials.gov		NCT00031707
Date Submitted to PDQ		2002-01-09
Information Last Verified		2007-11-23
NCI Grant/Contract Number		CA31946

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