CancerNCT01162642
Green Tea Anticancer Mechanisms in Smokers
A study testing Green Tea in people with Cancer, run by Philip Diaz at 1 site in United States.
Trial summary
The purpose of this study is to determine whether green tea may lower the risk of certain cancers. Read more about this study
- Who is it for?
- Ages 23 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- Green Tea
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Aug 2013
- 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 23 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy 23-40 year old males and non-pregnant females, who are moderately heavy smokers (1-1.75 packs/day, > 2 years)
Who cannot join
- Habitual tea intake
- Habitual flavonoid supplementation
- Soy product intake over twice a week (soy is high in flavonoids).
- Pulmonary diseases
- Chronic or acute infection
- Admission of heavy alcohol intake (> 14 beers or drinks a week)
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- Body mass index (BMI) > 30 (moderately overweight subjects will be taken)
- Abnormal EKG
- History of heart or other major health problems (ie arthritis, diabetes).
- Subjects with slightly high blood pressure will be eligible for the project, but more severe hypertension (>150/100)
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether green tea may lower the risk of certain cancers.
Read the detailed description
Green tea contains phytochemicals, especially flavonoids. Phytochemicals are not absolutely required for normal functions, but may confer health benefits such as antioxidant actions. One can live without phytochemicals, but one may live longer and better with them. The phytochemicals in tea have been proposed to inhibit cancer onset via several different mechanisms. An obvious question is: Can anti-cancer actions of green tea be duplicated by black tea, which in the USA, is consumed more than green tea? The question remains unanswered, and will not be addressed by this project since many questions about green tea have not been answered yet. The contents of both type teas overlap in flavonoids, but green tea has more of the agents thought to be most effective. For example, some of the research cited below uses the flavonoid epigallocatechin gallate. Green tea has 5 times more of this flavonoid than black tea.
This study has two purposes. First, a case will be made that green tea may have several anti-cancer mechanisms, but this contention is not well confirmed by human intervention studies. This case will be made by addressing four questions. Second, justification will be given for the choice of mechanisms to be examined in this project's human intervention.
- Conditions
- Cancer
- Being tested
- Green Tea, Placebo
- Keywords
- Healthy moderately heavy smokers
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Green TeaDietary supplement
Green Tea 4 cups daily
PlaceboOther
4 cups placebo tea for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Green Tea | Experimental | 4 cups daily of green tea for 6 weeks Receives: Dietary Supplement: Green Tea |
| No Green Tea | Placebo comparator | 4 cups daily of placebo tea for 6 weeks Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antioxidant effects of green tea versus placebo consumption.
Examine antioxidant effects of green tea versus placebo by measuring scavenging of free radicals; tea flavonoids; inflammatory cell secretion; endogenous antioxidant glutathione.
Measured: Measured at post treatment
Secondary outcomes (1)
Non-antioxidant, cancer-relevant effects of green tea consumption
Examine non-antioxidant, cancer-relevant effects of green tea by measuring NF-kappaB inducing kinase; phosphorylation of cell signaling agents; tumor necrosis factor gene expression; lysyl oxidase enzyme; blockage of cancer cell proliferation.
Measured: Measured at pre-treatment and post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2010 (estimated)
- Study startJun 2010
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philip Diaz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Philip Diaz, Ohio State University
- Investigators
- Philip Diaz, M.D., Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01162642
- Sponsor's protocol ID
- 2007C0109
- Status last verified
- Apr 2015
- First submitted
- 23 Jun 2010
- Last updated
- 21 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Green Tea Anticancer Mechanisms in Smokers
- ClinicalTrials.gov ID
- NCT01162642
- Acronym / sponsor ID
- 2007C0109
- Conditions
- Cancer
- Keywords
- Healthy moderately heavy smokers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Philip DiazUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 14 Jul 2010 (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.
The purpose of this study is to determine whether green tea may lower the risk of certain cancers.
Detailed description
Green tea contains phytochemicals, especially flavonoids. Phytochemicals are not absolutely required for normal functions, but may confer health benefits such as antioxidant actions. One can live without phytochemicals, but one may live longer and better with them. The phytochemicals in tea have been proposed to inhibit cancer onset via several different mechanisms. An obvious question is: Can anti-cancer actions of green tea be duplicated by black tea, which in the USA, is consumed more than green tea? The question remains unanswered, and will not be addressed by this project since many questions about green tea have not been answered yet. The contents of both type teas overlap in flavonoids, but green tea has more of the agents thought to be most effective. For example, some of the research cited below uses the flavonoid epigallocatechin gallate. Green tea has 5 times more of this flavonoid than black tea.
This study has two purposes. First, a case will be made that green tea may have several anti-cancer mechanisms, but this contention is not well confirmed by human intervention studies. This case will be made by addressing four questions. Second, justification will be given for the choice of mechanisms to be examined in this project's human intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Green Tea | Experimental | Dietary Supplement: Green Tea4 cups daily of green tea for 6 weeks |
| No Green Tea | Placebo comparator | Other: Placebo4 cups daily of placebo tea for 6 weeks |
Who may qualify
- Ages
- 23 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy 23-40 year old males and non-pregnant females, who are moderately heavy smokers (1-1.75 packs/day, > 2 years)
Key exclusion criteria (10 listed)
- Habitual tea intake
- Habitual flavonoid supplementation
- Soy product intake over twice a week (soy is high in flavonoids).
- Pulmonary diseases
- Chronic or acute infection
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 |
|---|---|---|
| Green TeaGreen Tea 4 cups daily | Dietary supplement | Green Tea |
| Placebo4 cups placebo tea for 6 weeks | Other | No Green Tea |
Primary outcome
Antioxidant effects of green tea versus placebo consumption.
Time frame: Measured at post treatment
Examine antioxidant effects of green tea versus placebo by measuring scavenging of free radicals; tea flavonoids; inflammatory cell secretion; endogenous antioxidant glutathione.
1 secondary outcome
Non-antioxidant, cancer-relevant effects of green tea consumption
Time frame: Measured at pre-treatment and post treatment
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 21 Apr 2015.
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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.
Philip Diaz, M.D. principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Green Tea in people with Cancer, run by Philip Diaz 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 1 inclusion and 10 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 21 Apr 2015. 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. Some participants in this study may receive a placebo. 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?
Antioxidant effects of green tea versus placebo consumption. (time frame: Measured at post 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 21 Apr 2015.