Lung Cancer PreventionPhase 2NCT02719860
High Tea Consumption on Smoking Related Oxidative Stress
A Phase 2 study testing Green tea and Black tea in people with Lung Cancer Prevention, run by University of Arizona.
Trial summary
The overall objective of this study is to determine the effect of high tea consumption on biological markers of oxidative stress that mediate lung cancer risk. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Lung Cancer Prevention
- What is being tested?
- Green tea and Black tea
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 154 participants
- Where
- No sites listed yet
- Study dates
- Sep 2003to Dec 2007
- Phase
- Phase 2
- 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 40 to 80 years
- All sexes
- Adult, Older adult
Who may be able to join
- FEV1 < 85% and at least 25 pack-years of current or former smoking history.
- No diagnosis of internal cancer within the last 5 years or no chemotherapy or radiation for an internal cancer within the last 5 years.
- Meets the Southwest Oncology Group (SWOG) performance status criteria of 0-1.
- Not be pregnant or intending to get pregnant during the study period (women participants).
- Willing to drink 4 cups of tea (each cup will be brewed with 2 tea bags and 12 ounces of water) for 1-month run-in period and for the 6-month intervention period.
- Willing to refrain from consuming other tea or tea products starting one month before the placebo run-in period and for the entire study period (a total of 8 months)
- Willing to refrain from consuming more than one caffeinated product (coffee, soda..) starting one month before the placebo run-in period and for the entire study period (a total of 8 months).
- Subjects cannot take mega-doses of vitamins during the trial. This is defined as more than 400 IU of vitamin E, 200 ug of selenium, or 1 gm of vitamin C per day, or more than the tolerable upper limits of any other supplement as defined in the Dietary Reference Intake panels developed by the Food and Nutrition Board under the Institute of Medicine. Such vitamin therapy must be discontinued at least 2 weeks prior to study entry.
Who cannot join
- Subjects immunosuppressed by virtue of medication or disease.
- Serious concurrent illness that could interfere with study regimen.
- Subjects with a history of invasive cancer within the past 5 years.
- Subjects who are drinking more than 5 cups of non-herbal tea per week.
- Subjects who cannot or are unwilling to consume caffeinated beverages.
- Subjects unable to perform forced expiratory maneuver during spirometry testing.
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- More than one acute emphysema exacerbation within the last 6 month -period .
- Subjects on oxygen.
- Women with positive urinary pregnancy test.
About this study
Official title: A Chemoprevention Trial to Study the Effects of High Tea Consumption on Smoking Related Oxidative Stress
The overall objective of this study is to determine the effect of high tea consumption on biological markers of oxidative stress that mediate lung cancer risk.
- Conditions
- Lung Cancer Prevention
- Being tested
- Green tea, Black tea, Placebo tea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Green teaDietary supplement
4 cups/day of green tea for 6 months; each cup is prepared by brewing 2 tea bags in 12 oz of water
Black teaDietary supplement
4 cups/day of black tea for 6 months; each cup is prepared by brewing 2 tea bags in 12 oz of water
Placebo teaDietary supplement
4 cups/day of placebo tea for 6 months; each cup is prepared by brewing 2 tea bags in 12 oz of water
| Study group | Role | What they receive |
|---|---|---|
| Green tea | Experimental | Not described Receives: Dietary Supplement: Green tea |
| Black tea | Experimental | Not described Receives: Dietary Supplement: Black tea |
| Placebo tea | Placebo comparator | Not described Receives: Dietary Supplement: Placebo tea |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-intervention change in urinary 8-hydroxydeoxyguanosine
Measured: Baseline and 6 months
Post-intervention change in urinary 8-F2-isoprostanes
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2016 (estimated)
- Study startSep 2003
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer PreventionStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02719860
- Sponsor's protocol ID
- 03-0014
- Status last verified
- Mar 2016
- First submitted
- 8 Mar 2016
- Last updated
- 25 Mar 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Chemoprevention Trial to Study the Effects of High Tea Consumption on Smoking Related Oxidative Stress
- ClinicalTrials.gov ID
- NCT02719860
- Acronym / sponsor ID
- 03-0014
- Conditions
- Lung Cancer Prevention
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- Sep 2003
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 25 Mar 2016 (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 overall objective of this study is to determine the effect of high tea consumption on biological markers of oxidative stress that mediate lung cancer risk.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Green tea | Experimental | Dietary Supplement: Green tea |
| Black tea | Experimental | Dietary Supplement: Black tea |
| Placebo tea | Placebo comparator | Dietary Supplement: Placebo tea |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- FEV1 < 85% and at least 25 pack-years of current or former smoking history.
- No diagnosis of internal cancer within the last 5 years or no chemotherapy or radiation for an internal cancer within the last 5 years.
- Meets the Southwest Oncology Group (SWOG) performance status criteria of 0-1.
- Not be pregnant or intending to get pregnant during the study period (women participants).
- Willing to drink 4 cups of tea (each cup will be brewed with 2 tea bags and 12 ounces of water) for 1-month run-in period and for the 6-month intervention period.
Key exclusion criteria (9 listed)
- Subjects immunosuppressed by virtue of medication or disease.
- Serious concurrent illness that could interfere with study regimen.
- Subjects with a history of invasive cancer within the past 5 years.
- Subjects who are drinking more than 5 cups of non-herbal tea per week.
- Subjects who cannot or are unwilling to consume caffeinated beverages.
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 tea4 cups/day of green tea for 6 months; each cup is prepared by brewing 2 tea bags in 12 oz of water | Dietary supplement | Green tea |
| Black tea4 cups/day of black tea for 6 months; each cup is prepared by brewing 2 tea bags in 12 oz of water | Dietary supplement | Black tea |
| Placebo tea4 cups/day of placebo tea for 6 months; each cup is prepared by brewing 2 tea bags in 12 oz of water | Dietary supplement | Placebo tea |
Primary outcome
Post-intervention change in urinary 8-hydroxydeoxyguanosine
Time frame: Baseline and 6 months
Post-intervention change in urinary 8-F2-isoprostanes
Time frame: Baseline and 6 months
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 25 Mar 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Green tea and Black tea in people with Lung Cancer Prevention, run by University of Arizona.
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 8 inclusion and 9 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 25 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
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?
Post-intervention change in urinary 8-hydroxydeoxyguanosine (time frame: Baseline and 6 months). The study lists 2 primary outcomes in all. 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 25 Mar 2016.