OBJECTIVES:
* Determine the efficacy of IH636 grape seed proanthocyanidin extract for the treatment of radiation-induced fibrosis after high-dose radiotherapy in women with a history of early breast cancer.
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to time since prior radiotherapy. Patients are randomized to 1 of 2 arms.
* Arm I: Patients receive oral IH636 grape seed proanthocyanidin extract three times daily for 6 months.
* Arm II: Patients receive an oral placebo three times daily for 6 months. Patients are followed at 6 months.
PROJECTED ACCRUAL: A total of 72 patients (48 for arm I and 24 for arm II) will be accrued for this study.
