This trial is active, not recruiting.

Conditions breast cancer, radiation fibrosis
Treatment ih636 grape seed proanthocyanidin extract
Phase phase 2
Sponsor Royal Marsden NHS Foundation Trust
Start date September 2002
Trial identifier NCT00041223, CDR0000069454, EU-20209, RMNHS-1991, RMNHS-GRAPE-1991


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Masking double-blind
Primary purpose supportive care

Eligibility Criteria

Female participants at least 18 years old.

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

Additional 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
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2013.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).