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Sponsored by: |
Royal Marsden - London |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00041223 |
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 Cancer-Related Problem/Condition |
Drug: IH636 grape seed proanthocyanidin extract |
Phase II |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Double-Blind, Placebo Control |
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 |
OBJECTIVES:
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.
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 |
DISEASE CHARACTERISTICS:
History of early breast cancer
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United Kingdom, England | |
Royal Marsden Hospital | |
Sutton, England, United Kingdom, SM2 5PT |
Study Chair: | John R. Yarnold, MD, FRCR | Royal Marsden - Surrey |
Study ID Numbers: | CDR0000069454, RMNHS-GRAPE-1991, RMNHS-1991, EU-20209 |
Study First Received: | July 8, 2002 |
Last Updated: | October 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00041223 |
Health Authority: | United States: Federal Government |
radiation fibrosis stage I breast cancer stage II breast cancer stage IIIA breast cancer |
Proanthocyanidin Procyanidin Skin Diseases |
Fibrosis Breast Neoplasms Breast Diseases |
Anti-Infective Agents Antiparasitic Agents Antiprotozoal Agents Neoplasms Antioxidants Neoplasms by Site |
Molecular Mechanisms of Pharmacological Action Therapeutic Uses Physiological Effects of Drugs Protective Agents Pharmacologic Actions |