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Development of Radiation Fibrosis in Patients Treated With Pentoxyphylline and Vitamin E: a Prospective Randomized Study

Phase 2
20 Years
Not Enrolling

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Trial Information

Development of Radiation Fibrosis in Patients Treated With Pentoxyphylline and Vitamin E: a Prospective Randomized Study

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

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Subjective, Objective, Management, and Analytic (SOMA) Score

Outcome Description:

A primary outcome of interest is the composite Subjective, Objective, Management, and Analytic (SOMA) score at 18-month follow-up visit. Maximum score is 45, with a score of 0 being ideal and representing no treatment-related side effects at the study visit.

Outcome Time Frame:

18 month post-treatment

Safety Issue:


Principal Investigator

Geraldine Jacobson, MD MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

department of radiation oncology


United States: Institutional Review Board

Study ID:




Start Date:

February 2003

Completion Date:

June 2012

Related Keywords:

  • Fibrosis
  • Breast Neoplasms
  • Radiotherapy
  • Fibrosis



The University of Iowa Hospitals & Clinics Iowa City, Iowa  52242