IH636 Grape Seed Extract in Treating Hardening of Breast Tissue in Women Who Have Undergone Radiation Therapy for Early Breast Cancer
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.
Dietary Supplement: IH636 grape seed proanthocyanidin extract
|Study Design:||Allocation: Randomized
Primary Purpose: Supportive Care
|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|
|Study Start Date:||September 2002|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00041223
|Royal Marsden Hospital|
|Sutton, England, United Kingdom, SM2 5PT|
|Study Chair:||John R. Yarnold, MD, FRCR||Royal Marsden NHS Foundation Trust|