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

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

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07682324

Acronym

GTE

Enrollment

Registered

2026-07-02

Start date

2026-09-30

Completion date

2029-03-01

Last updated

2026-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer Treatment, Neuropathic Pain

Keywords

green tea extract, GTE, neuropathic pain

Brief 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.

Interventions

DIETARY_SUPPLEMENTGreen 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.

OTHERPlacebo Control

Rice flour

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Contacts

CONTACTMichael Daniel, PhD

michael5@uab.edu205-975-0866

PRINCIPAL_INVESTIGATORMichael Daniel, PhD

University of Alabama at Birmingham

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 18, 2026