Green Tea in Breast Cancer Patients

NCT ID: NCT00949923

Last Updated: 2018-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-07

Study Completion Date

2016-06-06

Brief Summary

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Prognostic factors for breast cancer beyond stage at diagnosis and tumor characteristics have not been well studied. Of special interest are lifestyle factors that can be modified by women after diagnosis to increase disease-free survival. Green tea is rich in polyphenols consisting primarily of epicatechins, epigallocatechin, epicatechin gallate, and epigallocatechin gallate (EGCG). The investigators hypothesize that there will be a reduction in proliferation and/or an increase in apoptosis in association with short-term EGCG treatment.

Detailed Description

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Conditions

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Incident Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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tea capsules

3 tea capsules daily for 3 weeks

Group Type ACTIVE_COMPARATOR

tea capsule

Intervention Type DIETARY_SUPPLEMENT

3 tea capsules daily for 3 weeks

Control

No tea capsules

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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tea capsule

3 tea capsules daily for 3 weeks

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Green Tea Mega EGCG, ProHealth, Inc

Eligibility Criteria

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Inclusion Criteria

* Postmenopausal (at least 2 years since last menstrual period) or age 55 or older if prior hysterectomy
* Non-current (not with past 6 months) user of menopausal hormones
* Mammographic abnormality consistent with any type of incident breast cancer necessitating a diagnostic biopsy (BIRAD IV(b), (c) or V) will be sufficient to draw baseline LFT and complete screening questionnaire. Unless the biopsy confirms incident breast cancer, such subjects will not be included in further research interventions and they will not serve as EGCG treated or control subjects.
* Diagnosed with incident breast cancer on the diagnostic biopsy is required for inclusion in the EGCG or control treatment groups.
* Non-green tea drinker (less than monthly) - this criteria does not apply to black tea or herbal tea
* Provided written informed consent

Exclusion Criteria

* Green tea drinker (once per month or more)
* History of breast cancer or other cancer including a prior diagnosis of any type of incident breast cancer.
* Known allergy to tea
* Abnormal liver enzymes (plus or minus 10% of the normal ranges).
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Southern California

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anna Wu, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

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USC/Norris Comprehensive Cancer Center

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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HS-07-00731

Identifier Type: -

Identifier Source: secondary_id

1B-08-1

Identifier Type: -

Identifier Source: org_study_id

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