Incident Breast CancerNCT00949923
Green Tea in Breast Cancer Patients
A study testing tea capsule in people with Incident Breast Cancer, run by University of Southern California at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Incident Breast Cancer
- What is being tested?
- tea capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2008to 6 Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033
About this study
Official title: Green Tea Supplement in Women With Incident Breast Cancer
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.
- Conditions
- Incident Breast Cancer
- Being tested
- tea capsule
- Keywords
- Postmenopausal women, Suspicious for breast ca
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tea capsuleDietary supplement
Also called Green Tea Mega EGCG, ProHealth, Inc
3 tea capsules daily for 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| tea capsules | Active comparator | 3 tea capsules daily for 3 weeks Receives: Dietary Supplement: tea capsule |
| Control | No intervention | No tea capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
level of reduction in proliferation or increase in apoptosis in association with short-term EGCG
Measured: At surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2009 (estimated)
- Study start7 May 2008
- Primary completion14 Dec 2010
- Study completion6 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incident Breast CancerStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anna Wu, PhD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00949923
- Sponsor's protocol ID
- 1B-08-1
- Other IDs
- HS-07-00731
- Status last verified
- Mar 2018
- First submitted
- 29 Jul 2009
- Last updated
- 30 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Green Tea Supplement in Women With Incident Breast Cancer
- ClinicalTrials.gov ID
- NCT00949923
- Acronym / sponsor ID
- 1B-08-1
- Conditions
- Incident Breast Cancer
- Keywords
- Postmenopausal women, Suspicious for breast ca
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 7 May 2008 (actual)
- Primary completion
- 14 Dec 2010 (actual)
- Study completion
- 6 Jun 2016 (actual)
- First posted
- 31 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tea capsules | Active comparator | Dietary Supplement: tea capsule3 tea capsules daily for 3 weeks |
| Control | No intervention | –No tea capsules |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tea capsuleAlso: Green Tea Mega EGCG, ProHealth, Inc3 tea capsules daily for 3 weeks | Dietary supplement | tea capsules |
Primary outcome
level of reduction in proliferation or increase in apoptosis in association with short-term EGCG
Time frame: At surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2018.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Wu, PhD principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tea capsule in people with Incident Breast Cancer, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
level of reduction in proliferation or increase in apoptosis in association with short-term EGCG (time frame: At surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2018.