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


Phase 2/Phase 3
18 Years
N/A
Not Enrolling
Both
Lung Cancer, Prostate Cancer, Neoplasm Metastasis, Bone Cancer

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Diagnostic

Outcome Measure:

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

Principal Investigator

Charles R Thomas, Jr, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

U Texas Health Science Center San Antonio

Authority:

United States: Institutional Review Board

Study ID:

001-0015-211

NCT ID:

NCT00127387

Start Date:

May 2001

Completion Date:

November 2005

Related Keywords:

  • Lung Cancer
  • Prostate Cancer
  • Neoplasm Metastasis
  • Bone Cancer
  • 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
  • Bone Neoplasms
  • Osteosarcoma
  • Cachexia
  • Neoplasms
  • Lung Neoplasms
  • Neoplasm Metastasis
  • Prostatic Neoplasms
  • Stress Disorders, Post-Traumatic

Name

Location
University of Texas Health Science Center at San Antonio San Antonio, Texas  78284-7811