Enbrel Versus Placebo With Radiation Therapy to Combat Fatigue and Cachexia

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00127387
• Date of registration: 03/08/2005
• Primary sponsor: The University of Texas Health Science Center at San Antonio
• Public title: Enbrel Versus Placebo With Radiation Therapy to Combat Fatigue and Cachexia
• Scientific title: A Prospective, Randomized Pilot Study of Enbrel VS Placebo in Patients Receiving Radiation Therapy to Combat Fatigue and Cachexia
• Date of first enrolment: May 2001
• Target sample size: 54
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00127387
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Diagnostic

Countries of recruitment

United States

Contacts

• Name: Charles R Thomas, Jr, MD
• Affiliation: U Texas Health Science Center San Antonio

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Bone Cancer

Lung Cancer

Neoplasm Metastasis

Prostate Cancer

Intervention(s)

Drug: Enbrel

Primary Outcome(s)

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

Secondary Outcome(s)

Safety profile for enbrel taken by this group of individuals

Secondary ID(s)

001-0015-211

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Sanchez Cancer Center