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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2002 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
First received: July 8, 2002
Last updated: November 5, 2013
Last verified: September 2002

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 Intervention Phase
Breast Cancer
Radiation Fibrosis
Dietary Supplement: IH636 grape seed proanthocyanidin extract
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
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

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: September 2002
Detailed Description:


  • 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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over


  • Female

Menopausal status:

  • Not specified

Performance status:

  • Not specified

Life expectancy:

  • Not specified


  • Not specified


  • Not specified


  • Not specified


Biologic therapy:

  • Not specified


  • Not specified

Endocrine therapy:

  • Not specified


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


  • Not specified


  • At least 3 months since prior dietary supplementation containing IH636 grape seed proanthocyanidin extract over 50 mg per day
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00041223

United Kingdom
Royal Marsden Hospital
Sutton, England, United Kingdom, SM2 5PT
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
Study Chair: John R. Yarnold, MD, FRCR Royal Marsden NHS Foundation Trust
  More Information

ClinicalTrials.gov Identifier: NCT00041223     History of Changes
Other Study ID Numbers: CDR0000069454  RMNHS-GRAPE-1991  RMNHS-1991  EU-20209 
Study First Received: July 8, 2002
Last Updated: November 5, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
radiation fibrosis
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Radiation Pneumonitis
Breast Diseases
Lung Diseases
Lung Diseases, Interstitial
Lung Injury
Neoplasms by Site
Radiation Injuries
Respiratory Tract Diseases
Skin Diseases
Wounds and Injuries
Grape Seed Extract
Anti-Infective Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Antiparasitic Agents
Antiprotozoal Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Protective Agents

ClinicalTrials.gov processed this record on May 22, 2016