IH636 Grape Seed Extract in Preventing Breast Cancer in Postmenopausal Women at Risk of Developing Breast Cancer

City of Hope Medical Center37 enrolled

Overview

RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of IH636 grape seed extract may prevent breast cancer. PURPOSE: This phase I trial is studying the side effects and best dose of IH636 grape seed extract in preventing breast cancer in postmenopausal women at risk of developing breast cancer.

OBJECTIVES: * Determine the efficacy of IH636 grape seed proanthocyanidin extract, in terms of suppression of estrogen biosynthesis, in healthy post-menopausal women at high risk of developing breast cancer. * Determine the safety and tolerability of this dietary supplement, in terms of symptoms and changes in markers of bone and lipid metabolism and in markers of nonspecific adrenal suppression, in these participants. * Determine, preliminarily, an optimum biologic dose of this dietary supplement, as defined by suppression of serum estradiol, in these participants. * Determine a minimum duration of use of this dietary supplement to achieve aromatase inhibition in these participants. OUTLINE: This is a pilot, dose-finding, placebo-controlled study. Participants receive oral placebo once or twice daily on days -14 to 0. Participants then receive oral IH636 grape seed proanthocyanidin extract once or twice daily on days 1-85. Treatment continues in the absence of toxicity. Cohorts of 6 participants receive one of four dose levels of IH636 grape seed proanthocyanidin extract up to an established safe dose. PROJECTED ACCRUAL: A total of 24 participants will be accrued for this study within 12 months.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Breast Cancer

Interventions

IH636 grape seed proanthocyanidin extractDIETARY_SUPPLEMENT

Dose escalation as follows: 50 mg/day, 300 mg/day, 1000 mg/day, 2000 mg/day, 2800 mg/day, 4000 mg/day, 4800 mg/day and 6000 mg/day in separate patient groups for each dosage

Eligibility

Sex: FEMALEMin age: 40 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

DISEASE CHARACTERISTICS: * At risk of developing breast cancer * No history of breast cancer or ductal carcinoma in situ PATIENT CHARACTERISTICS: Age * 40 to 75 Sex * Female Menopausal status * Postmenopausal, defined by 1 of the following criteria: * No spontaneous menses for ≥ 12 months * Prior bilateral oophorectomy * Prior hysterectomy with follicle-stimulating hormone within menopausal range Performance status * ECOG 0-1 Life expectancy * Not specified Hematopoietic * Hemoglobin ≥ 9.0 g/dL * Platelet count ≥ 100,000/mm\^3 * WBC ≥ 3,500/mm\^3 * Absolute granulocyte count ≥ 1,500/mm\^3 * No coagulation disorders Hepatic * SGOT and SGPT ≤ 2 times upper limit of normal (ULN) * Bilirubin ≤ 1.5 times ULN Renal * Creatinine ≤ 1.5 times ULN Cardiovascular * No major illness of the cardiovascular system Pulmonary * No major illness of the respiratory system Other * No history of other invasive cancer within the past 5 years except squamous cell or basal cell skin cancer * No major systemic infection * No Cushing's syndrome or adrenal insufficiency * No osteoporosis, defined as a bone mineral density T-score ≥ -2.5 on dual-energy x-ray absorptiometry scan (calcium and/or cholecalciferol \[vitamin D\] supplementation AND/OR bisphosphonate therapy allowed provided participant is on a stable dose during study participation) PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * More than 3 months since prior hormone-modifying medications, including any of the following: * Oral contraceptives * Hormone replacement therapy * Selective estrogen receptor modifiers * Aromatase inhibitors * Gonadotropin-releasing hormone modifiers * Concurrent dehydroepiandrosterone (DHEA) allowed, provided dose remains constant during study participation Radiotherapy * Not specified Surgery * Not specified Other * No red wine, red grapes, or white button mushrooms directly before or during study treatment * White and seedless grapes allowed * No other concurrent therapy

Locations (1)

City of Hope Comprehensive Cancer Center

Duarte, California, United States

Outcomes

Primary Outcomes

Estrogen suppression as measured by serum estradiol, estrone, estrone sulfate, and sex hormone binding globulin

Time frame: at 1, 2, 4, 8, and 12 weeks

Secondary Outcomes

Androgenic effects as measured by serum testosterone, androstenedione, dehydroepiandrosterone (DHEA), and dehydroepiandrosterone sulfate (DHEAS)

Time frame: at 1, 2, 4, 8, and 12 weeks

Lipid effects as measured by total cholesterol, LDL, HDL, and triglycerides

Time frame: at 12 weeks

Bone metabolic effects as measured by bone-specific alkaline phosphatase and N-telopeptides

Time frame: at 12 weeks

Insulin regulatory effects as measured by insulin-like growth factor 1 (IGF1) and insulin-like growth factor-binding protein 3 (IGFBP3)

Time frame: at 12 weeks

Pharmacokinetics as measured by procyanidins

Time frame: before and after first dose and then at 1, 2, 4, 8, and 12 weeks

Data from ClinicalTrials.gov

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