Enbrel Versus Placebo With Radiation Therapy to Combat Fatigue and Cachexia

This study is currently recruiting participants.

Verified by The University of Texas Health Science Center at San Antonio, August 2005

First Received: August 3, 2005 Last Updated: August 23, 2005 History of Changes

Sponsors and Collaborators:	The University of Texas Health Science Center at San Antonio Sanchez Cancer Center
Information provided by:	The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:	NCT00127387

Purpose

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.

Condition	Intervention	Phase
Lung Cancer Prostate Cancer Neoplasm Metastasis Bone Cancer	Drug: Enbrel	Phase II Phase III

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Prospective, Randomized Pilot Study of Enbrel VS Placebo in Patients Receiving Radiation Therapy to Combat Fatigue and Cachexia

Resource links provided by NLM:

MedlinePlus related topics: Bone Cancer Cancer Lung Cancer Post-Traumatic Stress Disorder Prostate Cancer Radiation Therapy

Drug Information available for: Etanercept

U.S. FDA Resources

Further study details as provided by The University of Texas Health Science Center at San Antonio:

Primary Outcome Measures:

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:

Safety profile for enbrel taken by this group of individuals

Estimated Enrollment:	54
Study Start Date:	May 2001

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00127387

Contacts

Contact: Cecelia Simmons, RN, CCRC	210-616-5638	simmonsc@uthscsa.edu
Contact: Charles R Thomas, Jr, MD	210-616-5684	thomascr@uthscsa.edu

Locations

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

Sponsors and Collaborators

The University of Texas Health Science Center at San Antonio

Sanchez Cancer Center

Investigators

Principal Investigator:

Charles R Thomas, Jr, MD

U Texas Health Science Center San Antonio

More Information

No publications provided

Study ID Numbers:	001-0015-211
Study First Received:	August 3, 2005
Last Updated:	August 23, 2005
ClinicalTrials.gov Identifier:	NCT00127387 History of Changes
Health Authority:	United States: Institutional Review Board

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

Bone metastasis
Radiation therapy
Lung cancer
Prostate cancer

Advanced lung cancer receiving radiation therapy
Advanced prostate cancer receiving radiation therapy
Any cancer with bone mets receiving radiation therapy

Study placed in the following topic categories:

Thoracic Neoplasms
Anti-Inflammatory Agents
Immunologic Factors
Bone Neoplasms
Genital Neoplasms, Male
Prostatic Diseases
Cachexia
Urogenital Neoplasms
TNFR-Fc fusion protein
Bone Diseases
Stress Disorders, Traumatic
Musculoskeletal Diseases
Respiratory Tract Diseases
Lung Neoplasms
Mental Disorders

Neoplasm Metastasis
Stress Disorders, Post-Traumatic
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Fatigue
Stress
Genital Diseases, Male
Immunosuppressive Agents
Anxiety Disorders
Analgesics, Non-Narcotic
Lung Diseases
Peripheral Nervous System Agents
Antirheumatic Agents
Prostatic Neoplasms

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Thoracic Neoplasms
Immunologic Factors
Bone Neoplasms
Genital Neoplasms, Male
Prostatic Diseases
Physiological Effects of Drugs
Urogenital Neoplasms
TNFR-Fc fusion protein
Bone Diseases
Stress Disorders, Traumatic
Neoplastic Processes
Neoplasms by Site
Pathologic Processes
Respiratory Tract Diseases

Musculoskeletal Diseases
Sensory System Agents
Lung Neoplasms
Mental Disorders
Therapeutic Uses
Neoplasm Metastasis
Stress Disorders, Post-Traumatic
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Respiratory Tract Neoplasms
Gastrointestinal Agents
Genital Diseases, Male
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms

ClinicalTrials.gov processed this record on September 10, 2009