Ignite Creation Date:
2024-05-05 @ 9:33 PM
Last Modification Date:
2024-10-26 @ 10:06 AM
Study NCT ID:
NCT00917735
Status:
COMPLETED
Last Update Posted:
2016-02-22
First Post:
2009-06-08
Brief Title:
Green Tea and Reduction of Breast Cancer Risk
Sponsor:
University of Minnesota
Organization:
University of Minnesota
Study Overview
Official Title:
Phase II RandomizedDouble-blind Placebo-controlled Study of the Efficacy of Green Tea Extract on Biomarkers of Breast Cancer Risk in High Risk Women With Differing Catechol-O-methyl Transferase COMT Genotypes
Status:
COMPLETED
Status Verified Date:
2016-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
OBJECTIVES
1 Primary
11 To determine the effects of green tea extract consumption containing 800 mg EGCG per day for 12 months on the following recognized biomarkers of breast cancer risk
1 Mammographic density
2 Circulating concentrations of insulin-like growth factor 1 IGF-1 and IGF binding protein 3 IGFBP-3
3 Circulating concentrations of reproductive hormones estrone estradiol androstenedione and sex hormone binding globulin SHBG
12 To determine the effects of COMT genotype on the green tea extract effects described above
2 Secondary
21 To determine the effects of green tea extract consumption containing 800 mg EGCG per day for 12 months on the following hypothesized biomarkers of breast cancer risk
1 Urinary estrogen metabolites estrone estradiol and their 2-hydroxy 4-hydroxy 2-methoxy and 4-methoxy metabolites estriol and 16- hydroxyestrone
2 Circulating concentrations of F-2 isoprostanes a recognized biomarker of systemic oxidative stress
22 To determine the effects of COMT genotype on the green tea extract effects described above
23 To determine the effects of COMT genotype on catechin metabolism and excretion as measured by circulating and urinary concentrations
1 Primary
11 To determine the effects of green tea extract consumption containing 800 mg EGCG per day for 12 months on the following recognized biomarkers of breast cancer risk
1 Mammographic density
2 Circulating concentrations of insulin-like growth factor 1 IGF-1 and IGF binding protein 3 IGFBP-3
3 Circulating concentrations of reproductive hormones estrone estradiol androstenedione and sex hormone binding globulin SHBG
12 To determine the effects of COMT genotype on the green tea extract effects described above
2 Secondary
21 To determine the effects of green tea extract consumption containing 800 mg EGCG per day for 12 months on the following hypothesized biomarkers of breast cancer risk
1 Urinary estrogen metabolites estrone estradiol and their 2-hydroxy 4-hydroxy 2-methoxy and 4-methoxy metabolites estriol and 16- hydroxyestrone
2 Circulating concentrations of F-2 isoprostanes a recognized biomarker of systemic oxidative stress
22 To determine the effects of COMT genotype on the green tea extract effects described above
23 To determine the effects of COMT genotype on catechin metabolism and excretion as measured by circulating and urinary concentrations
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01CA127236 | NIH | None | httpsreporternihgovquickSearchR01CA127236 |