Clinical trial · Interventional
Genistein in Preventing Breast or Endometrial Cancer in Healthy Postmenopausal Women
Phase I Multiple Dose Clinical Study of Soy Isoflavones in Healthy, Post-Menopausal Women
NCT00099008CI-TRIAL-00010365completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 cancer. PURPOSE: This randomized phase I trial is studying the effectiveness of genistein in preventing breast or endometrial cancer in healthy postmenopausal women.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Genistein | Dietary Supplement | — | UNRESOLVED |
| Placebo | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Genistein
- interventionNames
- Dietary Supplement: Genistein
- type
- PLACEBO_COMPARATOR
- label
- Arm II
- description
- Placebo
- interventionNames
- Dietary Supplement: Placebo
Primary outcomes (1)
- measure
- Efficacy of genistein on DNA and apoptosis
- timeFrame
- 112 days
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 45 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTPop EA, Fischer LM, Coan AD, Gitzinger M, Nakamura J, Zeisel SH. Effects of a high daily dose of soy isoflavones on DNA damage, apoptosis, and estrogenic outcomes in healthy postmenopausal women: a phase I clinical trial. Menopause. 2008 Jul-Aug;15(4 Pt 1):684-92. doi: 10.1097/gme.0b013e318167b8f2. PMID 18446090