Daily, Encapsulated, Green Tea Extract to Mitigate Neuropathic Pain in Patients With Established Cancer-Associated Neuropathic Pain
NCT07682324 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2026-08-21
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
Interventions
- 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
-
Placebo Control
Rice flour
Sponsors & Collaborators
-
University of Alabama at Birmingham
lead OTHER
Principal Investigators
-
Michael Daniel, PhD · University of Alabama at Birmingham
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-09-30
- Primary Completion
- 2029-01-08
- Completion
- 2029-03-01
Countries
- United States
Study Locations
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