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

Alternate Title

Phase III Randomized Study of Modafinil for Fatigue in Cancer Patients Receiving Chemotherapy

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Supportive care	Completed	18 and over	NCI	URCC-U2901 NCI-5952, NCI-P02-0228, NCT00042848

Trial Description

Purpose:

Modafinil may be effective in relieving fatigue in patients with cancer who are undergoing chemotherapy. The effectiveness of modafinil in relieving chemotherapy-related fatigue is not yet known.

This randomized phase III trial is studying the effectiveness of modafinil in treating fatigue in patients who are receiving chemotherapy for cancer.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• Scheduled to receive at least four courses of chemotherapy
• No previous modafinil
• 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 two groups. Patients in group one will receive modafinil by mouth once a day beginning on day 5 of the second course of chemotherapy. Patients in group two will receive a placebo by mouth as in group one. Fatigue and quality of life will be assessed periodically.

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

University of Rochester Cancer Center CCOP Research Base

Gary Morrow, PhD, MS, Protocol chair		Ph: 585-275-5513

Related Information

Featured trial article

Registry Information
Official Title		Phase III Randomized, Placebo-Controlled, Double-Blind Trial Of The Effect Of Modafinil On Fatigue In Cancer Patients Receiving Chemotherapy
Trial Start Date		2002-08-05
Trial Completion Date		2007-10-01
Registered in ClinicalTrials.gov		NCT00042848
Date Submitted to PDQ		2002-06-03
Information Last Verified		2007-05-06
NCI Grant/Contract Number		CA037420

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