A Phase I Prevention Trial of ACTIVIN Grape Seed Extract as an Aromatase Inhibitor In Healthy Postmenopausal Women at Risk for Breast Cancer
40 Years
75 Years
Female
Breast Cancer
Trial Information
A Phase I Prevention Trial of ACTIVIN Grape Seed Extract as an Aromatase Inhibitor In Healthy Postmenopausal Women at Risk for 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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
Estrogen suppression as measured by serum estradiol, estrone, estrone sulfate, and sex hormone binding globulin
Outcome Time Frame:
at 1, 2, 4, 8, and 12 weeks
Safety Issue:
No
Authority:
United States: Institutional Review Board
Study ID:
03178
NCT ID:
NCT00100893
Start Date:
January 2005
Completion Date:
Related Keywords:
- Breast Cancer
- breast cancer
- Breast Neoplasms
Name | Location |
|---|---|
| City of Hope Comprehensive Cancer Center | Duarte, California 91010 |
