Enbrel Versus Placebo With Radiation Therapy to Combat Fatigue and Cachexia

The recruitment status of this study is unknown because the information has not been verified recently.

Verified August 2005 by The University of Texas Health Science Center at San Antonio. Recruitment status was Recruiting

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

Sponsor:	The University of Texas Health Science Center at San Antonio
Collaborator:	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:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Diagnostic
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 Fatigue Lung Cancer Post-Traumatic Stress Disorder Prostate Cancer

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

ClinicalTrials.gov Identifier:	NCT00127387 History of Changes
Other Study ID Numbers:	001-0015-211
Study First Received:	August 3, 2005
Last Updated:	August 23, 2005
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

Additional relevant MeSH terms:

Bone Neoplasms
Osteosarcoma
Cachexia
Neoplasms
Lung Neoplasms
Neoplasm Metastasis
Prostatic Neoplasms
Stress Disorders, Post-Traumatic
Neoplasms by Site
Bone Diseases
Musculoskeletal Diseases
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type

Sarcoma
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Neoplastic Processes
Pathologic Processes
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male

ClinicalTrials.gov processed this record on February 09, 2012