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Green Tea in Breast Cancer Patients

University of Southern California logo

University of Southern California

Status

Completed

Conditions

Incident Breast Cancer

Treatments

Dietary Supplement: tea capsule

Study type

Interventional

Funder types

Other

Identifiers

NCT00949923
1B-08-1
HS-07-00731

Details and patient eligibility

About

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.

Enrollment

41 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

41 participants in 2 patient groups

tea capsules
Active Comparator group
Description:
3 tea capsules daily for 3 weeks
Treatment:
Dietary Supplement: tea capsule
Control
No Intervention group
Description:
No tea capsules

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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