Double-Blind, Placebo-Controlled, Randomised Trial Of Alpha-Tocopherol And Oxpentifylline In Patients With Radiation Fibrosis
OBJECTIVES: I. Determine the effects of vitamin E and pentoxifylline on lymphedema in
patients previously treated with radiotherapy for breast cancer. II. Compare the normal
tissue injury and quality of life in patients treated with this regimen vs placebo.
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are
randomized to one of two treatment arms. Arm I: Patients receive oral vitamin E and oral
pentoxifylline twice daily for 6 months. Arm II: Patients receive oral placebo twice daily
for 6 months. Quality of life is assessed at baseline and at 3, 6, 9, and 12 months.
Patients are followed at 6 and 12 months.
PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this
Primary Purpose: Supportive Care
John R. Yarnold, MD, FRCR
Royal Marsden NHS Foundation Trust
United States: Federal Government