Breast Cancer Clinical Trial
Official title:
Double-Blind, Placebo-Controlled, Randomized Phase II Trial of IH636 Grape Seed Proanthocyanidin Extract (GSPE) in Patients With Adverse Effects of High Dose Breast Radiotherapy
RATIONALE: IH636 grape seed extract may lessen hardening of breast tissue caused by
radiation therapy and may help patients live more comfortably.
PURPOSE: Randomized phase II trial to study the effectiveness of IH636 grape seed extract in
treating hardening of breast tissue in women who have undergone radiation therapy for early
breast cancer.
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.
;
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
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