IH636 Grape Seed Extract in Preventing Breast Cancer in Postmenopausal Women at Risk of Developing Breast Cancer
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.
|Breast Cancer||Dietary Supplement: IH636 grape seed proanthocyanidin extract||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||A Phase I Prevention Trial of ACTIVIN Grape Seed Extract as an Aromatase Inhibitor In Healthy Postmenopausal Women at Risk for Breast Cancer|
- 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 ]
- 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 ]
|Study Start Date:||January 2005|
|Study Completion Date:||October 2013|
|Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
Experimental: Dietary Supplement: grape seed proanthocyanidin extract
Dietary Supplement: IH636 grape seed proanthocyanidin extract
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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00100893
|United States, California|
|City of Hope Comprehensive Cancer Center|
|Duarte, California, United States, 91010-3000|