Ductal Carcinoma in SituPhase 2NCT01060345
A Pilot Study of Chemo-prevention of Green Tea in Women With Ductal Carcinoma in Situ
A Phase 2 study testing Polyphenon E in people with Ductal Carcinoma in Situ, run by University of Chicago at 1 site in United States.
Trial summary
The purpose of this study is to find molecular signs (biomarkers) to better understand the role of green tea as an anti-cancer and anti-inflammation agent in women with newly-diagnosed ductal carcinoma in situ (DCIS). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ductal Carcinoma in Situ
- What is being tested?
- Polyphenon E
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Sep 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Histologically confirmed DCIS by breast core biopsy with a corresponding lesion on breast MRI of at least 1-cm3 in volume.
- Patients may have undergone treatment with prior chemotherapy if this was greater than 12 months prior to current diagnosis.
- Age >18 years.
- ECOG performance status <2 (Karnofsky >60%)
- Life expectancy of greater than 12 months.
- Normal organ and marrow function as defined below:
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- leukocytes >3,000/mcL
- absolute neutrophil count >1,500/mcL
- platelets >100,000/mcL
- total bilirubin within normal institutional limits
- AST(SGOT) \& ALT(SGPT)within normal institutional limits
- creatinine <1.5 times institutional upper limit of normal or creatinine clearance >60 mL/min/1.73 m2
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Pregnancy
- Patients who have undergone prior excisional biopsy for DCIS.
- Patients who are unable to undergo MRI due to claustrophobia or other reason.
- Patients with ipsilateral treatment for DCIS or breast cancer within 12 months prior to entering this study.
- Patients receiving any other chemotherapy or investigational agents.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to green tea extracts or sensitivity to green tea.
- Uncontrolled concurrent illness including, but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of Chemo-prevention of Green Tea in Women With Ductal Carcinoma in Situ (DCIS)
The purpose of this study is to find molecular signs (biomarkers) to better understand the role of green tea as an anti-cancer and anti-inflammation agent in women with newly-diagnosed ductal carcinoma in situ (DCIS).
Read the detailed description
Many studies have shown that green tea may have anti-cancer and anti-inflammatory effects in cancer cells and animal models of breast cancer. Some studies have found that Asian women who drink many cups of green tea have lower rates of breast cancer. Green tea may have an effect on proliferative and inflammatory pathways. Women with ductal carcinoma in situ (DCIS) have been found to have inflammation in the breast tissue surrounding DCIS lesions. Inflammatory pathways are being studied for a possible link to cancer. This study is designed to evaluate changes in biomarkers of proliferation, inflammation, and angiogenesis in response to green tea intake.
- Conditions
- Ductal Carcinoma in Situ
- Being tested
- Polyphenon E
- Keywords
- DCIS
- Medical subject headings
- Carcinoma, Intraductal, Noninfiltrating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyphenon EDrug
Also called Green tea
three 200mg capsules (600mg total dose of the study drug) with food (within one hour of eating a substantial meal) daily for a minimum of 4 weeks, or until the day before surgery
| Study group | Role | What they receive |
|---|---|---|
| Women with Ductal Carcinoma in Situ | Experimental | Women who have been diagnosed with ductal carcinoma in situ (DCIS) and will be taking Polyphenon E Receives: Drug: Polyphenon E |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in K167 Staining
Measured: Prior to starting study and after 4-6 weeks of treatment
Secondary outcomes (6)
Decrease in MRI Volume and Signal Enhancement Ratio (SER) of the Breast Lesion From Pre- to Post-treatment.
Measured: Prior to study start and 4-6 weeks after treatment
Change in Percent Staining of CD68 in Breast Tissue
Measured: Prior to study start and 4-6 weeks after treatment
Change in Percent Staining of CD31 in Breast Tissue
Measured: Prior to study start and 4-6 weeks after treatment
Change in Percent Staining of VEGF in Breast Tissue
Measured: Prior to study start and after 4-6 weeks of treatment
Change in Serum Levels of IGF-1
Measured: Prior to study start and after 4-6 weeks of treatment
Safety of Green Tea Ingestion
Number of patients with adverse event.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2010 (estimated)
- Study startMay 2010
- Primary completionSep 2015
- Study completionSep 2015
Why it stopped: Drug no longer available
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ductal Carcinoma in SituStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nora Jaskowiak, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01060345
- Sponsor's protocol ID
- 09-151-B
- Status last verified
- Mar 2020
- First submitted
- 29 Jan 2010
- Last updated
- 9 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Chemo-prevention of Green Tea in Women With Ductal Carcinoma in Situ (DCIS)
- ClinicalTrials.gov ID
- NCT01060345
- Acronym / sponsor ID
- 09-151-B
- Conditions
- Ductal Carcinoma in Situ
- Keywords
- DCIS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Drug no longer available
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 2 Feb 2010 (estimated)
- Results
- Posted 9 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to find molecular signs (biomarkers) to better understand the role of green tea as an anti-cancer and anti-inflammation agent in women with newly-diagnosed ductal carcinoma in situ (DCIS).
Detailed description
Many studies have shown that green tea may have anti-cancer and anti-inflammatory effects in cancer cells and animal models of breast cancer. Some studies have found that Asian women who drink many cups of green tea have lower rates of breast cancer. Green tea may have an effect on proliferative and inflammatory pathways. Women with ductal carcinoma in situ (DCIS) have been found to have inflammation in the breast tissue surrounding DCIS lesions. Inflammatory pathways are being studied for a possible link to cancer. This study is designed to evaluate changes in biomarkers of proliferation, inflammation, and angiogenesis in response to green tea intake.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women with Ductal Carcinoma in Situ | Experimental | Drug: Polyphenon EWomen who have been diagnosed with ductal carcinoma in situ (DCIS) and will be taking Polyphenon E |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Histologically confirmed DCIS by breast core biopsy with a corresponding lesion on breast MRI of at least 1-cm3 in volume.
- Patients may have undergone treatment with prior chemotherapy if this was greater than 12 months prior to current diagnosis.
- Age >18 years.
- ECOG performance status <2 (Karnofsky >60%)
- Life expectancy of greater than 12 months.
Key exclusion criteria (7 listed)
- Pregnancy
- Patients who have undergone prior excisional biopsy for DCIS.
- Patients who are unable to undergo MRI due to claustrophobia or other reason.
- Patients with ipsilateral treatment for DCIS or breast cancer within 12 months prior to entering this study.
- Patients receiving any other chemotherapy or investigational agents.
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 |
|---|---|---|
| Polyphenon EAlso: Green teathree 200mg capsules (600mg total dose of the study drug) with food (within one hour of eating a substantial meal) daily for a minimum of 4 weeks, or until the day before surgery | Drug | Women with Ductal Carcinoma in Situ |
Primary outcome
Percent Change in K167 Staining
Time frame: Prior to starting study and after 4-6 weeks of treatment
6 secondary outcomes
Decrease in MRI Volume and Signal Enhancement Ratio (SER) of the Breast Lesion From Pre- to Post-treatment.
Time frame: Prior to study start and 4-6 weeks after treatment
Change in Percent Staining of CD68 in Breast Tissue
Time frame: Prior to study start and 4-6 weeks after treatment
Change in Percent Staining of CD31 in Breast Tissue
Time frame: Prior to study start and 4-6 weeks after treatment
Change in Percent Staining of VEGF in Breast Tissue
Time frame: Prior to study start and after 4-6 weeks of treatment
Change in Serum Levels of IGF-1
Time frame: Prior to study start and after 4-6 weeks of treatment
Safety of Green Tea Ingestion
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Nora Jaskowiak, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Polyphenon E in people with Ductal Carcinoma in Situ, run by University of Chicago 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 13 inclusion and 7 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: stopped early, as of the sponsor's last update on 9 Apr 2020. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent Change in K167 Staining (time frame: Prior to starting study and after 4-6 weeks of treatment). 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 9 Apr 2020.