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Enbrel Versus Placebo With Radiation Therapy to Combat Fatigue and Cachexia

Information source: The University of Texas Health Science Center at San Antonio
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Lung Cancer; Prostate Cancer; Neoplasm Metastasis; Bone Cancer

Intervention: Enbrel (Drug)

Phase: Phase 2/Phase 3

Status: Recruiting

Sponsored by: The University of Texas Health Science Center at San Antonio

Official(s) and/or principal investigator(s):
Charles R Thomas, Jr, MD, Principal Investigator, Affiliation: U Texas Health Science Center San Antonio

Overall contact:
Cecelia Simmons, RN, CCRC, Phone: 210-616-5638, Email: simmonsc@uthscsa.edu

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.

Clinical Details

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

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

Primary outcome: Determine if the subjects who received the enbrel study drug had a better quality of life than the subjects who received placebo

Secondary outcome: Safety profile for enbrel taken by this group of individuals

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Cecelia Simmons, RN, CCRC, Phone: 210-616-5638, Email: simmonsc@uthscsa.edu

University of Texas Health Science Center at San Antonio, San Antonio, Texas 78229, United States; Recruiting
Cecelia Simmons, RN, CCRC, Phone: 210-616-5638, Email: simmonsc@uthscsa.edu
Charles R Thomas, Jr, MD, Phone: 210-616-5684, Email: thomascr@uthscsa.edu
Charles R Thomas, Jr, MD, Principal Investigator
Additional Information

Starting date: May 2001
Last updated: August 23, 2005

Page last updated: October 04, 2010

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