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Green Tea in Breast Cancer Patients

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StatusDovršeno
Sponzori
University of Southern California

Ključne riječi

Sažetak

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.

Datumi

Posljednja provjera: 02/28/2018
Prvo podneseno: 07/28/2009
Predviđena prijava poslana: 07/29/2009
Prvo objavljeno: 07/30/2009
Posljednje ažuriranje poslano: 03/27/2018
Posljednje ažuriranje objavljeno: 03/29/2018
Stvarni datum početka studija: 05/06/2008
Procijenjeni datum primarnog završetka: 12/13/2010
Procijenjeni datum završetka studije: 06/05/2016

Stanje ili bolest

Incident Breast Cancer

Intervencija / liječenje

Dietary Supplement: tea capsules

Faza

-

Grupe ruku

RukaIntervencija / liječenje
Active Comparator: tea capsules
3 tea capsules daily for 3 weeks
Dietary Supplement: tea capsules
3 tea capsules daily for 3 weeks
No Intervention: Control
No tea capsules

Kriterij prihvatljivosti

Dobni uvjeti za studiranje 18 Years Do 18 Years
Spolovi koji ispunjavaju uvjete za studijFemale
Prihvaća zdrave volontereDa
Kriteriji

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).

Ishod

Primarne mjere ishoda

1. level of reduction in proliferation or increase in apoptosis in association with short-term EGCG [At surgery]

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