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

NCT07682324 | Not Yet Recruiting Phase 2 DMC

• 2 other identifiers: IRB-300016025UAB School of Nursing
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuropathic Pain; Cancer Treatment

Keywords

green tea extract; GTE; neuropathic pain

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, end of treatment (up to 16 weeks).

Study Arms (2)

Green Tea Extract

EXPERIMENTAL

Dietary Supplement: Green Tea Leaf Extract Decaffeinated

Placebo

PLACEBO COMPARATOR

Other: Placebo Control

Interventions

Green Tea Leaf Extract Decaffeinated DIETARY_SUPPLEMENT

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.

Also known as: Sunphenon 90D

Green Tea Extract

Placebo Control OTHER

Rice flour

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Neuralgia

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Daniel, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Daniel, PhD

CONTACT

205-975-0866; michael5@uab.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 26, 2026
• First Posted: July 2, 2026
• Study Start (Estimated): September 30, 2026
• Primary Completion (Estimated): January 8, 2029
• Study Completion (Estimated): March 1, 2029
• Last Updated: July 17, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)