Enbrel Versus Placebo With Radiation Therapy to Combat Fatigue and Cachexia

June 22, 2012 updated by: The University of Texas Health Science Center at San Antonio

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

54

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78229
        • University of Texas Health Science Center at San Antonio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
Safety profile for enbrel taken by this group of individuals

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center at San Antonio

Collaborators

Sanchez Cancer Center

Investigators

  • Principal Investigator: Charles R Thomas, Jr, MD, U Texas Health Science Center San Antonio

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2001

Primary Completion (Actual)

September 1, 2005

Study Completion (Actual)

November 1, 2005

Study Registration Dates

First Submitted

August 3, 2005

First Submitted That Met QC Criteria

August 4, 2005

First Posted (Estimate)

August 5, 2005

Study Record Updates

Last Update Posted (Estimate)

June 26, 2012

Last Update Submitted That Met QC Criteria

June 22, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 001-0015-211

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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