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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

NCT ID: NCT00041223

Last Updated: 2013-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2002-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Breast Cancer Radiation Fibrosis

Keywords

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radiation fibrosis stage I breast cancer stage II breast cancer stage IIIA breast cancer

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Interventions

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IH636 grape seed proanthocyanidin extract

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Royal Marsden NHS Foundation Trust

OTHER

Sponsor Role lead

Principal Investigators

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John R. Yarnold, MD, FRCR

Role: STUDY_CHAIR

Royal Marsden NHS Foundation Trust

Locations

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Royal Marsden Hospital

Sutton, England, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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RMNHS-GRAPE-1991

Identifier Type: -

Identifier Source: secondary_id

RMNHS-1991

Identifier Type: -

Identifier Source: secondary_id

EU-20209

Identifier Type: -

Identifier Source: secondary_id

CDR0000069454

Identifier Type: -

Identifier Source: org_study_id