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NCT00917735 · ClinicalTrials.gov registry record · Phase 2
Green Tea and Reduction of Breast Cancer Risk
A Phase 2 study, sponsored by University of Minnesota.
- Completed
- Registry status
- Phase 2
- Development phase
- 1,075
- Enrollment target
NCT00917735 is a Phase 2 study that has completed, run by University of Minnesota. The registered enrollment target is 1,075 participants.
The verdict
NCT00917735, a Phase 2 study, has completed, sponsored by University of Minnesota.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 1,075 participants
- Enrollment target
Study Summary
RATIONALE: Green tea extract contains ingredients (catechins) that may lower the risk of breast cancer. PURPOSE: This phase II trial is studying how well green tea extract works in preventing breast cancer compared to a placebo in postmenopausal women with high breast density. The investigators have hypothesized that green tea consumption reduces breast cancer risk, and this effect is seen primarily in women who have the low-activity COMT genotype. The investigators will test this by evaluating the effects of green tea extract on breast cancer biomarkers including mammographic density, plasma insulin-like growth factor 1 (IGF-1), IGF binding protein 3 (IGFBP-3), estrone, estradiol, androstenedione, sex hormone binding globulin (SHBG), urinary estrogen metabolites and plasma F2-isoprostanes.
Interventions
- OTHER Placebo
- DRUG Green tea extract supplement
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,075 participants |
| Start Date | 2009-07 |
| Est. Completion | 2014-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00917735
The ClinicalTrials.gov registry entry for NCT00917735 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 1,075 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Minnesota, which has 966 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00917735 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00917735 about?
NCT00917735 is a clinical study titled "Green Tea and Reduction of Breast Cancer Risk". RATIONALE: Green tea extract contains ingredients (catechins) that may lower the risk of breast cancer. PURPOSE: This phase II trial is studying how well green tea extract works in preventing breast cancer compared to a placebo in postmenopausal women with high breast density. The investigators ha...
What is the current status of trial NCT00917735?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 1,075 participants. The study started on 2009-07. Estimated completion is 2014-06.
What interventions are being tested in trial NCT00917735?
The interventions under investigation include: Placebo (OTHER), Green tea extract supplement (DRUG).
Who is sponsoring clinical trial NCT00917735?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
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