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
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.
Interventional
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
John R. Yarnold, MD, FRCR
Study Chair
Royal Marsden NHS Foundation Trust
United States: Federal Government
CDR0000069454
NCT00041223
September 2002
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