Clinical trial · Interventional
IH636 Grape Seed Extract in Preventing Breast Cancer in Postmenopausal Women at Risk of Developing Breast Cancer
A Phase I Prevention Trial of ACTIVIN Grape Seed Extract as an Aromatase Inhibitor In Healthy Postmenopausal Women at Risk for Breast Cancer
NCT00100893CI-TRIAL-00018202completedPhase 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 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.
Conditions
Conditions (1)
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 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IH636 grape seed proanthocyanidin extract | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dietary Supplement: grape seed proanthocyanidin extract
- description
- Administered orally.
- interventionNames
- Dietary Supplement: IH636 grape seed proanthocyanidin extract
Primary outcomes (1)
- measure
- Estrogen suppression as measured by serum estradiol, estrone, estrone sulfate, and sex hormone binding globulin
- timeFrame
- at 1, 2, 4, 8, and 12 weeks
Secondary outcomes (5)
- measure
- Androgenic effects as measured by serum testosterone, androstenedione, dehydroepiandrosterone (DHEA), and dehydroepiandrosterone sulfate (DHEAS)
- timeFrame
- at 1, 2, 4, 8, and 12 weeks
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.