Status:
COMPLETED
IH636 Grape Seed Extract in Preventing Breast Cancer in Postmenopausal Women at Risk of Developing Breast Cancer
Lead Sponsor:
City of Hope Medical Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
FEMALE
40-75 years
Phase:
PHASE1
Brief Summary
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...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00100893
Start Date
January 1 2005
End Date
October 1 2013
Last Update
June 8 2015
Active Locations (1)
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1
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000