Status:
COMPLETED
Genistein in Preventing Breast or Endometrial Cancer in Healthy Postmenopausal Women
Lead Sponsor:
UNC Lineberger Comprehensive Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Endometrial Cancer
Eligibility:
FEMALE
45-70 years
Phase:
PHASE1
Brief Summary
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of genistein may be effective in preventing breast or endometrial canc...
Detailed Description
OBJECTIVES: * Compare the effects of genistein vs placebo on DNA damage and apoptosis by conducting COMET, TUNEL, Caspase-3, and AP site assays in healthy postmenopausal women. * Compare the effects ...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Healthy participants
- Papanicolaou test (pap smear) normal within the past 13 months
- Mammogram normal within the past 13 months
- No history of breast cancer
- Not at high-risk (5-year risk \< 1.9%) for breast cancer according to NCI's Breast Cancer Risk Assessment Tool
- Hormone receptor status:
- Not specified
- PATIENT CHARACTERISTICS:
- Age
- 45 to 70
- Sex
- Female
- Menopausal status
- Postmenopausal
- Last spontaneous menstrual bleeding \> 12 months ago
- Performance status
- ECOG 0-2
- Life expectancy
- Not specified
- Hematopoietic
- WBC ≥ 3,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hepatic
- Bilirubin ≤ 2.0 mg/dL
- ALT and AST \< 2 times normal
- No significant abnormality of the liver by physical exam
- Renal
- Creatinine \< 2.0 mg/dL
- Cardiovascular
- No significant cardiac disease
- No New York Heart Association class III or IV heart disease
- No significant abnormality of the heart by physical exam
- Pulmonary
- No significant abnormality of the lung by physical exam
- Other
- Body mass index \< 35
- Follicle-stimulating hormone \> 27 mIU/mL
- Thyroid or endocrine function test normal
- Alcohol intake ≤ 2 drinks/day or ≤14 drinks/week
- Not pregnant
- No intermediate equol values (≥10 ug/L to ≤ 20 ug/L) on soy challenge
- No history of seizures
- No significant abnormality of the spleen or other abdominal organs by physical exam
- No neurologic abnormality by physical exam
- No significant metabolic abnormality on the biochemical screen
- No history of substance abuse or addiction
- No tobacco use
- No diets containing \> 20 mg of genistein/day or \> 40 mg isoflavone/day
- No known intolerance to soy
- No other serious medical illness
- No active malignancy or malignancy initially diagnosed within the past 2 years except curatively treated nonmelanoma skin cancer
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- Not specified
- Chemotherapy
- More than 2 years since prior chemotherapy
- No concurrent chemotherapy
- Endocrine therapy
- More than 3 months since prior hormonal or estrogen therapy
- More than 3 months since prior tamoxifen or other selective estrogen-receptor modulators
- More than 1 month since prior supplements containing phytoestrogens or that have estrogenic side effects (soy isoflavones or PC-SPECS)
- No concurrent thyroid medication
- Other concurrent endocrine medication allowed provided medication was initiated ≥ 3 months before study entry AND participant has been on a stable regimen for the past 3 months
- Radiotherapy
- Not specified
- Surgery
- No prior hysterectomy or oophorectomy
- Other
- More than 3 months since prior antibiotics
Exclusion
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2006
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00099008
Start Date
March 1 2004
End Date
July 1 2006
Last Update
May 21 2013
Active Locations (1)
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1
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7295