IH636 Grape Seed Extract in Treating Hardening of Breast Tissue in Women Who Have Undergone Radiation Therapy for Early Breast Cancer
|ClinicalTrials.gov Identifier: NCT00041223|
Recruitment Status : Unknown
Verified September 2002 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : November 6, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Radiation Fibrosis||Dietary Supplement: IH636 grape seed proanthocyanidin extract||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|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|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00041223
|Royal Marsden Hospital|
|Sutton, England, United Kingdom, SM2 5PT|
|Study Chair:||John R. Yarnold, MD, FRCR||Royal Marsden NHS Foundation Trust|