IH636 Grape Seed Extract in Treating Hardening of Breast Tissue in Women Who Have Undergone Radiation Therapy for Early Breast Cancer
This trial is active, not recruiting.
|Conditions||breast cancer, radiation fibrosis|
|Treatment||ih636 grape seed proanthocyanidin extract|
|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.
|Primary purpose||supportive care|
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
|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.|
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