Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

IH636 Grape Seed Extract in Treating Hardening of Breast Tissue in Women Who Have Undergone Radiation Therapy for Early Breast Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Supportive care	Closed	18 and over	Other	RMNHS-GRAPE-1991 RMNHS-1991, EU-20209, NCT00041223

Objectives

1. 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.

Entry Criteria

Disease Characteristics:

• History of early breast cancer
  • T1-T3, N0-N1, M0



• No evidence of cancer recurrence



• Palpable breast induration due to prior radiotherapy



• Hormone receptor status:
  • Not specified

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• Not specified

Endocrine therapy:

• Not specified

Radiotherapy:

• See Disease Characteristics
• At least 2 years since prior radiotherapy

Surgery:

• Not specified

Other:

• At least 3 months since prior dietary supplementation containing IH636 grape seed proanthocyanidin extract over 50 mg per day

Patient Characteristics:

Age:

• 18 and over

Sex:

• Female

Menopausal status:

• Not specified

Performance status:

• Not specified

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• Not specified

Expected Enrollment

A total of 72 patients (48 for arm I and 24 for arm II) will be accrued for this study.

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.

Trial Contact Information

Trial Lead Organizations

Royal Marsden - London

John Yarnold, MD, FRCR, Protocol chair		Ph: 44-20-8661-3388

Registry Information
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
Trial Start Date		2002-09-10
Registered in ClinicalTrials.gov		NCT00041223
Date Submitted to PDQ		2002-05-28
Information Last Verified		2002-09-27