View Trial - USC Norris Cancer Center Clinical Trials

Details for trial 1B-08-1

Description:	Pilot Study of Green Tea Supplement in Women with Ductal Carcinoma in Situ.
Status:	Open
Randomized?	No

Researchers

Principal Investigator	Title
Anna Wu	Ph.D.

Data Management

Name	Title
Kristy Watkins	R.N.
Jackie Major	R.N.

You may participate in this study if:

	Requirement
1	Postmenopausal (at least 2 years since last menstrual period) or age 55 or older if prior hysterectomy
2	Non-current (i.e., not with past 6 months) user of menopausal hormones
3	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.
4	Diagnosed with incident breast cancer on the diagnostic biopsy is required for inclusion in the EGCG or control treatment groups.
5	Non-green tea drinker (i.e., less than monthly) – this criteria does not apply to black tea or herbal tea
6	Patient must have signed and dated IRB approved informed consent and HIPAA authorization forms.

You may not participate in this study if:

1	Green tea drinker (i.e., once per month or more)
2	History of breast cancer or other cancer including a prior diagnosis of any type of incident breast cancer
3	Known allergy to tea
4	Abnormal liver enzymes (±10% of the normal ranges).

For further information on, or to sign up for this study, please contact the Clinical Investigation Support Office at (323) 865-0451 or the Principal Investigator noted above.