Trial | NCT00127387  Report issue

Title

Enbrel Versus Placebo With Radiation Therapy to Combat Fatigue and Cachexia
A Prospective, Randomized Pilot Study of Enbrel VS Placebo in Patients Receiving Radiation Therapy to Combat Fatigue and Cachexia

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    54
Patients who receive radiation therapy often have fatigue or a decrease in feeling well causing a "wasting" away. For patients with advanced disease of lung cancer, prostate cancer, or cancer that has spread to the bone, it is hoped that this drug may decrease this. If patients feel better during treatments they can complete the therapy without any breaks in treatment. For treatment to be most effective, it should be given in the amount needed, on a particular schedule.
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.
Study Started
May 31
2001
Primary Completion
Sep 30
2005
Study Completion
Nov 30
2005
Last Update
Jun 26
2012
Estimate

Drug Enbrel

Criteria 

Inclusion Criteria:

Advanced lung, prostate, or bony metastasis for cancer
Performance status (PS) of 3 or less
Good lab test results with albumin of at least 2.5
Radiation therapy of at least 4000Gy in 4 weeks

Exclusion Criteria:

Poor PS
Planned radiation therapy for less than 4 weeks or 4000Gy
Limited disease
No Results Posted