Trental & Vitamin E for Radiation-Induced Fibrosis

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2010

Detailed 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.

Interventions

  • Drug: Pentoxifylline
    • Pentoxifylline 400 mg, 3 times daily for 7 months, beginning immediately after radiation therapy.
  • Drug: Vitamin E
    • Vitamin E (Over-the-counter) 400 I.U. once daily

Arms, Groups and Cohorts

  • No Intervention: 1
    • Control for study – watchful waiting.
  • Experimental: 2
    • Combined treatment with Pentoxifylline and Vitamin E.

Clinical Trial Outcome Measures

Primary Measures

  • Subjective, Objective, Management, and Analytic (SOMA) Score
    • Time Frame: 18 month post-treatment
    • 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.

Secondary Measures

  • Tissue Compliance
    • Time Frame: 18 months post-treatment
    • Tissue compliance meter measurements of the treated breast compared to the non-treated breast were obtained at 18 months post-radiation therapy. Tissue compliance simply means how soft and pliable the breast tissue is when force is applied to it. One physician would hold the tissue compliance meter (TCM) against the participant’s skin. A standard amount of force would be applied. A second physician would read the displacement scale for a specific set of areas on the breast. The range of the scale was 0 to 60 milimeters (mm). The physician’s were blineded to the participant’s intervention at the time of measurement. The final value is the difference between the untreated and the treated breast [untreated - treated]. The range of these differences was -3.3 to 7.0 mm.

Participating 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

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Iowa
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Geraldine Jacobson, MD MPH, Principal Investigator, department of radiation oncology

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.

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