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Enbrel Versus Placebo With Radiation Therapy to Combat Fatigue and Cachexia

This study has been terminated.
(PI moved to Oregon)
Sponsor:
Collaborator:
Sanchez Cancer Center
Information provided by:
The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:
NCT00127387
First received: August 3, 2005
Last updated: June 22, 2012
Last verified: June 2012
History of Changes
  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 2
Phase 3

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:

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
Study Completion Date: November 2005
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
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

Locations
United States, Texas
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
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: June 22, 2012
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 June 17, 2013