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Enbrel Versus Placebo With Radiation Therapy to Combat Fatigue and Cachexia

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

Status
Terminated
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00127387
Enrollment
54
Registered
2005-08-05
Start date
2001-05-31
Completion date
2005-11-30
Last updated
2012-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Cancer, Lung Cancer, Neoplasm Metastasis, Prostate Cancer

Keywords

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

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.

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.

Interventions

DRUGEnbrel

Sponsors

Sanchez Cancer Center
CollaboratorOTHER
The University of Texas Health Science Center at San Antonio
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
Determine if the subjects who received the enbrel study drug had a better quality of life than the subjects who received placebo

Secondary

MeasureTime frame
Safety profile for enbrel taken by this group of individuals

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026