Name of the Trial
Phase III Randomized Study of Modafinil for Fatigue in Cancer Patients Receiving Chemotherapy (URCC-U2901). See the protocol summary at http://cancer.gov/clinicaltrials/URCC-U2901.

Principal Investigator
Dr. Gary Morrow of the University of Rochester Cancer Center in New York.

Why Is This Trial Important?
Fatigue affects many people with cancer, especially those receiving treatment. Fatigue is complex and has biological, psychological, and behavioral causes.

Research suggests that the drug modafinil, a stimulant, may be effective in relieving fatigue. This study is testing the ability of modafinil to reduce fatigue in cancer patients who are receiving chemotherapy. The study will also examine the relationship between depression and fatigue in patients treated with modafinil.

"Fatigue related to cancer and to cancer treatment are important issues, especially for patients," said Dr. Lori Minasian, chief of the National Cancer Institute's Community Oncology and Prevention Trials Research Group. "Modafinil is one of the more innovative means of treating fatigue, since it works on the body's central nervous system. With this trial, NCI-supported researchers are pursuing a different approach in combating the fatigue that often accompanies treatment for cancer."

Who Can Join This Trial?
The modafinil trial seeks to enroll 837 cancer patients age 18 and older who are currently undergoing chemotherapy. More information can be found at http://cancer.gov/clinicaltrials/URCC-U2901.

Where Is This Trial Taking Place?
Multiple study sites in the United States are enrolling patients in the modafinil trial. See the list of study sites at http://cancer.gov/clinicaltrials/URCC-U2901.

Who to Contact
See the list of study contacts at http://cancer.gov/clinicaltrials/URCC-U2901 or call the National Cancer Institute's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). The call is toll-free and completely confidential.