A Prospective, Randomized Pilot Study of Enbrel VS Placebo in Patients Receiving Radiation Therapy to Combat Fatigue and Cachexia
Subjects will be placed in a group to receive either the drug enbrel, or a placebo. The
radiation therapy treatments are as they would be given if the person was not on a research
study. The selection of the group a patient is in is done by random, like flipping a coin.
The doctor is not able to influence which group anyone is selected for. As is done
routinely, radiation therapy is given Monday through Friday for about 4 to 6 weeks.The
injections of enbrel or placebo are given two times a week. The enbrel or placebo is given
as an injection directly under the skin with a small needle.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Diagnostic
Determine if the subjects who received the enbrel study drug had a better quality of life than the subjects who received placebo
Charles R Thomas, Jr, MD
Principal Investigator
U Texas Health Science Center San Antonio
United States: Institutional Review Board
001-0015-211
NCT00127387
May 2001
November 2005
Name | Location |
---|---|
University of Texas Health Science Center at San Antonio | San Antonio, Texas 78284-7811 |