Neuropathic PainPhase 1GTENCT07682324
Daily, Encapsulated, Green Tea Extract to Mitigate Neuropathic Pain in Patients With Established Cancer-Associated Neuropathic Pain
A Phase 1 study testing Green Tea Leaf Extract Decaffeinated in people with Neuropathic Pain and Cancer Treatment, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The overall objective of this study is to test an intervention of green tea extract (GTE) to mitigate neuropathic pain in patients, specifically cancer survivors, receiving supportive palliative care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuropathic Pain, Cancer Treatment
- What is being tested?
- Green Tea Leaf Extract Decaffeinated
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2026to 1 Mar 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older.
- Established cancer-associated neuropathic pain.
- A baseline Douler Neuropathique 4 (DN4) patient-reported neuropathic pain questionnaire score of greater than or equal to 4.
- A stable pain management medication regimen, with no more than a 10% change in dosage in the past 14 days prior to enrollment.
- No known allergy to rice or rice flour (basis of placebo).
Who cannot join
- Actively undergoing cancer treatment.
- Symptoms and/or diagnosis of diabetic peripheral neuropathy.
- Self-describe as consuming more than 3 cups of green tea or matcha beverages on a daily basis.
- High probability of completing the study and all study-related measures/activities required by the protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Michael Daniel, PhD, 205-975-0866, michael5@uab.edu
Michael Daniel, PhD
About this study
Official title: Daily, Encapsulated, Green Tea Extract (GTE) to Mitigate Neuropathic Pain in Patients With Established Cancer-Associated Neuropathic Pain
The overall objective of this study is to test an intervention of green tea extract (GTE) to mitigate neuropathic pain in patients, specifically cancer survivors, receiving supportive palliative care. The central hypothesis is that daily, oral, encapsulated GTE will mitigate neuropathic pain, as longitudinally measured by the validated Douleur Neuropathique 4 (DN4) and blood protein biomarkers reported to be linked to the development and/or chronicity of neuropathic pain.
- Conditions
- Neuropathic Pain, Cancer Treatment
- Being tested
- Green Tea Leaf Extract Decaffeinated, Placebo Control
- Keywords
- green tea extract, GTE, neuropathic pain
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Green Tea Leaf Extract DecaffeinatedDietary supplement
Also called Sunphenon 90D
A purified green tea powder containing ~90% total polyphenols, more than 80% catechins (greater than or equal to 45% EGCG), and less than 1% caffeine.
Placebo ControlOther
Rice flour
| Study group | Role | What they receive |
|---|---|---|
| Green Tea Extract | Experimental | Not described Receives: Dietary Supplement: Green Tea Leaf Extract Decaffeinated |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in neuropathic pain score
Douleur Neuropathique 4 (DN4) pain questionnaire. On a scale of 0 to 10, a score of equal to or greater than 4 equals neuropathic pain.
Measured: Baseline, end of treatment (up to 16 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study start30 Sep 2026 (estimated)
- Primary completion8 Jan 2029 (estimated)
- Study completion1 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Daniel, University of Alabama at Birmingham
- Investigators
- Michael Daniel, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07682324
- Sponsor's protocol ID
- IRB-300016025
- Other IDs
- UAB School of Nursing
- Acronym
- GTE
- Status last verified
- Jul 2026
- First submitted
- 26 Jun 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Daily, Encapsulated, Green Tea Extract (GTE) to Mitigate Neuropathic Pain in Patients With Established Cancer-Associated Neuropathic Pain
- ClinicalTrials.gov ID
- NCT07682324
- Acronym / sponsor ID
- GTE / IRB-300016025
- Conditions
- Neuropathic Pain, Cancer Treatment
- Keywords
- green tea extract, GTE, neuropathic pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 8 Jan 2029 (estimated)
- Study completion
- 1 Mar 2029 (estimated)
- First posted
- 2 Jul 2026 (actual)
- 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 test an intervention of green tea extract (GTE) to mitigate neuropathic pain in patients, specifically cancer survivors, receiving supportive palliative care. The central hypothesis is that daily, oral, encapsulated GTE will mitigate neuropathic pain, as longitudinally measured by the validated Douleur Neuropathique 4 (DN4) and blood protein biomarkers reported to be linked to the development and/or chronicity of neuropathic pain.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Green Tea Extract | Experimental | Dietary Supplement: Green Tea Leaf Extract Decaffeinated |
| Placebo | Placebo comparator | Other: Placebo Control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years of age or older.
- Established cancer-associated neuropathic pain.
- A baseline Douler Neuropathique 4 (DN4) patient-reported neuropathic pain questionnaire score of greater than or equal to 4.
- A stable pain management medication regimen, with no more than a 10% change in dosage in the past 14 days prior to enrollment.
- No known allergy to rice or rice flour (basis of placebo).
Key exclusion criteria (4 listed)
- Actively undergoing cancer treatment.
- Symptoms and/or diagnosis of diabetic peripheral neuropathy.
- Self-describe as consuming more than 3 cups of green tea or matcha beverages on a daily basis.
- High probability of completing the study and all study-related measures/activities required by the protocol.
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 Tea Leaf Extract DecaffeinatedAlso: Sunphenon 90DA purified green tea powder containing ~90% total polyphenols, more than 80% catechins (greater than or equal to 45% EGCG), and less than 1% caffeine. | Dietary supplement | Green Tea Extract |
| Placebo ControlRice flour | Other | Placebo |
Primary outcome
Change in neuropathic pain score
Time frame: Baseline, end of treatment (up to 16 weeks).
Douleur Neuropathique 4 (DN4) pain questionnaire. On a scale of 0 to 10, a score of equal to or greater than 4 equals neuropathic pain.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Michael Daniel, PhD principal investigator
University of Alabama at Birmingham
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 Green Tea Leaf Extract Decaffeinated in people with Neuropathic Pain and Cancer Treatment, run by University of Alabama at Birmingham 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 5 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: opening soon, as of the sponsor's last update on 21 Aug 2026. 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.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Daniel, PhD (205-975-0866, michael5@uab.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in neuropathic pain score (time frame: Baseline, end of treatment (up to 16 weeks).). 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 Aug 2026.