This study seeks to determine if a combination of Trental and Vitamin E prevents the development of radiation fibrosis in women treated with radiation for the definitive management of their breast cancer...
Date First Received: December 20, 2007
Last Updated: June 9, 2008
Verified by: University of Iowa, June 2008
Clinical Trial Phase: Phase 2 | Start Date: February 2003
Overall Status: Recruiting
Estimated Enrollment: 56
Brief Summary
Official Title: “Development of Radiation Fibrosis in Patients Treated With Pentoxyphylline and Vitamin E: a Prospective Randomized Study”
Condition Keyword(s):
Intervention(s):
This study seeks to determine if a combination of Trental and Vitamin E prevents the development of radiation fibrosis in women treated with radiation for the definitive management of their breast cancer.
Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Parallel Assignment, Efficacy Study
Detailed Clinical Trial Description
Radiation fibrosis occurs in approximately 25% of those women treated with radiation for breast cancer. Of these, approximately 3 to 5% will develop into an acute, painful form of fibrosis. Mild fibrosis can present as a thicker or more dense breast where the acute form can cause pain in the breast, significant hardening, and inflammation.
Treatments for fibrosis are lacking, with the primary treatment being hyperbaric oxygen therapy. The combination of Trental & Vitamin E has been used with success in Europe and at the University of Iowa.
The focus of this study is to prevent fibrosis through intervention with Trental & Vitamin E.
The study has two arms, a control arm and an intervention arm. The study is not blinded.
Measurements are taken at standard follow-up visits to measure breast density and lymphedema.
Outcome Measures for this Clinical Trial
Primary:
- The primary outcome of interest is composite SOMA score at 18-month follow-up visit 18 month post-treatment No
Secondary:
- Tissue compliance of the treated breast compared to the non-treated breast 12 and 18 months post-treatment No
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Patients with histologically documented cancer of the breast or DCIS or head and neck referred for definitive radiation with curative intent.
- No evidence of metastatic disease.
- Minimum life expectancy of at least 12 months.
- Aged greater than 20 years.
- If female, pregnancy excluded.
- No documented history of collagen vascular disease.
Exclusion Criteria:
- Cognitively impaired patients
- Prisoners
- No histology available
- Documented metastatic disease
- Allergy to Trental
- Life expectance of less than 12 months.
- Aged less than 20 years
- Collagen vascular disease present
- Pregnant
- History of liver disease
- Use of anticoagulants
Clinical Trials Locations, Contact Details, and Sponsors
Lead Sponsor: University of Iowa
The University of Iowa Hospitals & Clinics
Iowa City Iowa 52242 United States
Overall Clinical Trial Officials and Contacts
Geraldine Jacobson, MD MPH Principal Investigator department of radiation oncology
Overall Contact: Kellie Bodeker, B.Sc., CCRC (319) 384-9425 kellie-bodeker@uiowa.edu
Related Publications
References
Dion MW, Hussey DH, Doornbos JF, Vigliotti AP, Wen BC, Anderson B. Preliminary results of a pilot study of pentoxifylline in the treatment of late radiation soft tissue necrosis. Int J Radiat Oncol Biol Phys. 1990 Aug;19(2):401-7.
Delanian S, Balla-Mekias S, Lefaix JL. Striking regression of chronic radiotherapy damage in a clinical trial of combined pentoxifylline and tocopherol. J Clin Oncol. 1999 Oct;17(10):3283-90.
Delanian S, Porcher R, Balla-Mekias S, Lefaix JL. Randomized, placebo-controlled trial of combined pentoxifylline and tocopherol for regression of superficial radiation-induced fibrosis. J Clin Oncol. 2003 Jul 1;21(13):2545-50.
Gothard L, Cornes P, Earl J, Hall E, MacLaren J, Mortimer P, Peacock J, Peckitt C, Woods M, Yarnold J. Double-blind placebo-controlled randomised trial of vitamin E and pentoxifylline in patients with chronic arm lymphoedema and fibrosis after surgery and radiotherapy for breast cancer. Radiother Oncol. 2004 Nov;73(2):133-9.
Delanian S, Porcher R, Rudant J, Lefaix JL. Kinetics of response to long-term treatment combining pentoxifylline and tocopherol in patients with superficial radiation-induced fibrosis. J Clin Oncol. 2005 Dec 1;23(34):8570-9. Epub 2005 Oct 31.
Additional Information
Information obtained from ClinicalTrials.gov on July 23, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00583700
Study ID Number: 200211003
ClinicalTrials.gov Identifier: NCT00583700
Health Authority: United States: Institutional Review Board
Clinical Trials Authorship and Review
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