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

Phase 1Not Yet RecruitingNCT07682324

University of Alabama at Birmingham20 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Enrollment

Conditions

Neuropathic Pain Cancer Treatment

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

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