Daily, Encapsulated, Green Tea Extract to Mitigate Neuropathic Pain in Patients With Established Cancer-Associated Neuropathic Pain (GTE)

June 26, 2026 updated by: Michael Daniel, University of Alabama at Birmingham

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. Our 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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham
        • Contact:
        • Principal Investigator:
          • Michael Daniel, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Other: Placebo Control
Rice flour
Experimental: Green Tea Extract
Dietary supplement: Green Tea Leaf Extract Decaffeinated
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.
Other Names:
  • Sunphenon 90D

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, end of treatment (up to 16 weeks).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Investigators

  • Principal Investigator: Michael Daniel, PhD, University of Alabama at Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 30, 2026

Primary Completion (Estimated)

January 8, 2029

Study Completion (Estimated)

March 1, 2029

Study Registration Dates

First Submitted

June 26, 2026

First Submitted That Met QC Criteria

June 26, 2026

First Posted (Actual)

July 2, 2026

Study Record Updates

Last Update Posted (Actual)

July 2, 2026

Last Update Submitted That Met QC Criteria

June 26, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-300016025
  • UAB School of Nursing (Other Identifier: UAB School of Nursing)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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