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Enbrel Versus Placebo With Radiation Therapy to Combat Fatigue and Cachexia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00127387
Recruitment Status : Terminated (PI moved to Oregon)
First Posted : August 5, 2005
Last Update Posted : June 26, 2012
Sanchez Cancer Center
Information provided by:
The University of Texas Health Science Center at San Antonio

Brief 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.

Condition or disease Intervention/treatment Phase
Lung Cancer Prostate Cancer Neoplasm Metastasis Bone Cancer Drug: Enbrel Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Diagnostic
Official Title: A Prospective, Randomized Pilot Study of Enbrel VS Placebo in Patients Receiving Radiation Therapy to Combat Fatigue and Cachexia
Study Start Date : May 2001
Actual Primary Completion Date : September 2005
Actual Study Completion Date : November 2005

Primary Outcome Measures :
  1. 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 :
  1. Safety profile for enbrel taken by this group of individuals

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00127387

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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
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Principal Investigator: Charles R Thomas, Jr, MD U Texas Health Science Center San Antonio
Layout table for additonal information Identifier: NCT00127387    
Other Study ID Numbers: 001-0015-211
First Posted: August 5, 2005    Key Record Dates
Last Update Posted: June 26, 2012
Last Verified: June 2012
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:
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Lung Neoplasms
Prostatic Neoplasms
Neoplasm Metastasis
Bone Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Prostatic Diseases
Neoplastic Processes
Pathologic Processes
Weight Loss
Body Weight Changes
Body Weight
Bone Diseases
Musculoskeletal Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs