Unspecified Adult Solid Tumor, Protocol SpecificPhase 1NCT00091325
Green Tea Extract (Polyphenon E) in Preventing Cancer in Healthy Participants
A Phase 1 study testing defined green tea catechin extract in people with Unspecified Adult Solid Tumor, Protocol Specific, run by University of Arizona at 1 site in United States.
Trial summary
RATIONALE: Green tea extract (Polyphenon E) contains ingredients that may prevent the development of cancer. PURPOSE: This phase I trial is studying how well green tea extract works in preventing cancer in healthy participants. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- defined green tea catechin extract
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Oct 2004to Mar 2005
- Phase
- Phase 1
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Healthy individuals
- Non-smokers
- More than 1 year since smoking cessation
- No concurrent smokers
- No regular consumption of large amounts of alcohol
- On average, ≤ 3 alcoholic drinks per week
- Consumes < 6 cups or glasses of tea per week
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance Status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Bilirubin ≤ 2.0 mg/dL
- AST or ALT ≤ 2 times normal
- Alkaline phosphatase ≤ 2 times normal
Renal
- Creatinine ≤ 1.5 mg/dL
Cardiovascular
- Resting systolic blood pressure ≥ 100 mm Hg
- No hypertension or hypercholesterolemia requiring unscheduled medical visits or changes in treatment within the past 3 months
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Willing to refrain from tea and related products and oral herbal/botanical supplements during study participation
- Willing to limit the consumption of cruciferous vegetables to ≤ once a week during study participation
- Willing to refrain from caffeine-containing food or beverages (e.g., coffee, colas, chocolate, or over-the-counter medications) for 72 hours before, during, and for 8 hours after study drug administration
- Willing to refrain from food items that affect drug or carcinogen metabolizing enzymes (e.g., grapefruit, grapefruit juice, cruciferous vegetables, and food cooked over charcoal) for 72 hours before, during, and for 8 hours after study drug administration
- No difficulty swallowing capsules or tablets
- No metabolic disorder known to affect study drugs
- No other serious acute or chronic disease (e.g., type I or II diabetes, cystic fibrosis, or active infection)
- No known hypersensitivity to green tea or probe drugs (e.g., caffeine, dextromethorphan, losartan, or buspirone)
- No invasive cancer (i.e., non-skin cancer) within the past 5 years
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Other
- More than 3 months since prior participation in another clinical intervention study
- No concurrent medications or supplements that are known P450 enzyme inducers or inhibitors
Trial locations and contacts
1 site in 1 country.
United States1 site
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, 85724
About this study
Official title: Phase I Drug Interaction Clinical Study of Polyphenon E
RATIONALE: Green tea extract (Polyphenon E) contains ingredients that may prevent the development of cancer.
PURPOSE: This phase I trial is studying how well green tea extract works in preventing cancer in healthy participants.
Read the detailed description
OBJECTIVES:
Primary
- Determine the effect of green tea extract (Polyphenon E) on cytochrome P450 enzyme activities and glutathione S-transferase activities and levels in healthy participants.
Secondary
- Determine the safety and tolerability of this drug in these participants.
OUTLINE: This is an open-label study.
Participants receive oral green tea extract (Polyphenon E) once daily for 4 weeks in the absence of unacceptable toxicity.
Participants are followed for 2 weeks.
PROJECTED ACCRUAL: A total of 44 participants will be accrued for this study.
- Being tested
- defined green tea catechin extract
- Keywords
- unspecified adult solid tumor, protocol specific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
defined green tea catechin extractDietary supplement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2004 (estimated)
- Study startOct 2004
- Primary completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unspecified Adult Solid Tumor, Protocol SpecificStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Prevention
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- H. H. Sherry Chow, PhD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00091325
- Sponsor's protocol ID
- CDR0000387801
- Other IDs
- P30CA023074, UARIZ-HSC-0499
- Status last verified
- Jan 2010
- First submitted
- 7 Sep 2004
- Last updated
- 20 Jan 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Drug Interaction Clinical Study of Polyphenon E
- ClinicalTrials.gov ID
- NCT00091325
- Acronym / sponsor ID
- CDR0000387801
- Keywords
- unspecified adult solid tumor, protocol specific
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2004
- Primary completion
- Mar 2005 (actual)
- First posted
- 9 Sep 2004 (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.
RATIONALE: Green tea extract (Polyphenon E) contains ingredients that may prevent the development of cancer.
PURPOSE: This phase I trial is studying how well green tea extract works in preventing cancer in healthy participants.
Detailed description
OBJECTIVES:
Primary
- Determine the effect of green tea extract (Polyphenon E) on cytochrome P450 enzyme activities and glutathione S-transferase activities and levels in healthy participants.
Secondary
- Determine the safety and tolerability of this drug in these participants.
OUTLINE: This is an open-label study.
Participants receive oral green tea extract (Polyphenon E) once daily for 4 weeks in the absence of unacceptable toxicity.
Participants are followed for 2 weeks.
PROJECTED ACCRUAL: A total of 44 participants will be accrued for this study.
Study design
- Primary purpose
- Prevention
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| defined green tea catechin extract | Dietary supplement | – |
Primary outcome
Not reported in the source record.
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 20 Jan 2010.
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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.
H. H. Sherry Chow, PhD principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing defined green tea catechin extract in people with Unspecified Adult Solid Tumor, Protocol Specific, run by University of Arizona 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?
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 20 Jan 2010. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
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 20 Jan 2010; AzTrials last refreshed its copy on 26 Oct 2026.