Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00127387
Status:
TERMINATED
Last Update Posted:
2012-06-26
First Post:
2005-08-03
Brief Title:
Enbrel Versus Placebo With Radiation Therapy to Combat Fatigue and Cachexia
Sponsor:
The University of Texas Health Science Center at San Antonio
Organization:
The University of Texas Health Science Center at San Antonio
Study Overview
Official Title:
A Prospective Randomized Pilot Study of Enbrel VS Placebo in Patients Receiving Radiation Therapy to Combat Fatigue and Cachexia
Status:
TERMINATED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI moved to Oregon
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 weeksThe 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None