Enbrel Versus Placebo With Radiation Therapy to Combat Fatigue and Cachexia

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00127387
• Other study ID #: 001-0015-211
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: August 3, 2005
• Last updated: June 22, 2012
• Start date: May 2001
• Est. completion date: November 2005

Study information

• Verified date: June 2012
• Source: The University of Texas Health Science Center at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 54
• Est. completion date: November 2005
• Est. primary completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Bone Cancer
• Lung Cancer
• Neoplasm Metastasis
• Prostate Cancer
• Prostatic Neoplasms
• Stress Disorders, Post-Traumatic

Intervention

Drug:
• Enbrel

Locations

Country	Name	City	State
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio	Sanchez Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine if the subjects who received the enbrel study drug had a better quality of life than the subjects who received placebo
Secondary	Safety profile for enbrel taken by this group of individuals