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Sponsors and Collaborators: |
The University of Texas Health Science Center at San Antonio Sanchez Cancer Center |
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Information provided by: | The University of Texas Health Science Center at San Antonio |
ClinicalTrials.gov Identifier: | NCT00127387 |
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 |
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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 |
Estimated Enrollment: | 54 |
Study Start Date: | May 2001 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Cecelia Simmons, RN, CCRC | 210-616-5638 | simmonsc@uthscsa.edu |
Contact: Charles R Thomas, Jr, MD | 210-616-5684 | thomascr@uthscsa.edu |
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 |
Principal Investigator: | Charles R Thomas, Jr, MD | U Texas Health Science Center San Antonio |
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 |
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 |
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 |
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 |