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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Study Description
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Brief Summary:

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

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Masking: Double
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

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

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00041223


Locations
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United Kingdom
Royal Marsden Hospital
Sutton, England, United Kingdom, SM2 5PT
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
Investigators
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Study Chair: John R. Yarnold, MD, FRCR Royal Marsden NHS Foundation Trust
More Information
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ClinicalTrials.gov Identifier: NCT00041223    
Other Study ID Numbers: CDR0000069454
RMNHS-GRAPE-1991
RMNHS-1991
EU-20209
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: November 6, 2013
Last Verified: September 2002
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:
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Breast Neoplasms
Fibrosis
Radiation Fibrosis Syndrome
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Pathologic Processes
Radiation Injuries
Wounds and Injuries
 Proanthocyanidin
Procyanidin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents