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

NCT07682324 — Phase 1, Not yet recruiting, 20 participants, University of Alabama at Birmingham

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

Registry	NCT07682324, acronym GTE
Status	Not yet recruiting
Phase	Phase 1
Study type	Interventional; randomized, parallel, masking: quadruple, supportive care
Enrollment	20 (Estimated)
Sponsor	University of Alabama at Birmingham (Other)
Conditions	Neuropathic Pain, Cancer Treatment
Interventions	Green Tea Leaf Extract Decaffeinated, Placebo Control (Dietary supplement, other)
Dates	start 2026-09-30 (estimated), primary completion 2029-01-08 (estimated), completion 2029-03-01 (estimated), first posted 2026-07-02, last updated 2026-08-21
Locations	1 site in United States

-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. 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.

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+Arms and interventions

Arm	Type	Interventions	Description
Green Tea Extract	Experimental	Dietary Supplement: Green Tea Leaf Extract Decaffeinated
Placebo	Placebo comparator	Other: Placebo Control

Green Tea Leaf Extract Decaffeinated (Dietary supplement), also known as 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 Control (Other): Rice flour

+Outcome measures

Primary outcomes

Change in neuropathic pain score [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.

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Locations (1)

Facility	City	Country	Status
University of Alabama at Birmingham	Birmingham, Alabama	United States

+Investigators

Michael Daniel, PhD, Principal investigator, University of Alabama at Birmingham