Enbrel Versus Placebo With Radiation Therapy to Combat Fatigue and Cachexia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Prospective, Randomized Pilot Study of Enbrel VS Placebo in Patients Receiving Radiation Therapy to Combat Fatigue and Cachexia

Conditions
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Lung Cancer, Prostate Cancer, Neoplasm Metastasis, Bone Cancer

Intervention / Treatment
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* Drug: Enbrel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Enbrel|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety profile for enbrel taken by this group of individuals |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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