Enbrel Versus Placebo With Radiation Therapy to Combat Fatigue and Cachexia

Phase 2

Terminated

• Conditions: Bone Cancer; Prostate Cancer; Lung Cancer; Neoplasm Metastasis

• Registration Number: NCT00127387
• Lead Sponsor: The University of Texas Health Science Center at San Antonio

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2001-05
• Study First Submitted: 2005-08-03
• Study First Submitted QC: 2005-08-04
• Study First Posted: 2005-08-05
• Primary Completion: 2005-09
• Study Completion: 2005-11
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-22
• Last Update Posted: 2012-06-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Determine if the subjects who received the enbrel study drug had a better quality of life than the subjects who received placebo

Secondary Outcome Measures

Name	Time	Method
Safety profile for enbrel taken by this group of individuals

Trial Locations

Locations (1)

University of Texas Health Science Center at San Antonio; 🇺🇸 San Antonio, Texas, United States