Trial of Pentoxifylline in Patients With Functional Disability Caused by Radiation-Induced Advanced Regional Fibrosis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00001437|
Recruitment Status : Completed
First Posted : December 10, 2002
Last Update Posted : March 4, 2008
|Condition or disease||Intervention/treatment||Phase|
|Fibrosis Radiation Injuries||Drug: pentoxifylline||Phase 2|
Patients with late fibrovascular sequelae of radiation or of combined radiation and surgery, with quantifiable symptomatology or disability, will be eligible for this trial. This protocol is designed as an open label one arm study. (A placebo controlled randomized trial was approved by the IRB but after extensive negotiation, drug and placebo in slow release formulation will not be provided by the manufacturer). Up to fifty patients will be recruited. After initial assessment of their condition by specified clinical and laboratory parameters, each of the patients will be treated for 8 weeks at the standard pentoxifylline dose (400 mg po TID). Objective and subjective response parameters will be re-assessed at the end of the treatment and 8 weeks later for possible decay of response.
In addition to symptomatic objective and subjective response, blood and urine will be collected for TNF, TGF-beta, and FGF. Cutaneous blood flow and collagen subtyping will be performed on a subset of patients using Laser Doppler, functional MRI techniques and subcutaneous tissue biopsies. We will examine for correlation between clinical response and these biological responses.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Official Title:||Trial of Pentoxifylline in Patients With Functional Disability Caused by Radiation-Induced Advanced Regional Fibrosis|
|Study Start Date :||June 1995|
|Estimated Study Completion Date :||March 2000|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001437
|United States, Maryland|
|National Cancer Institute (NCI)|
|Bethesda, Maryland, United States, 20892|