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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT07682324
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Cancer Treatment
  • Neuropathic Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • Placebo Control — OTHER
    Rice flour

Study Details

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. Our 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.

Key Dates

Start date
Sep 30, 2026
Status verified
Jun 2026
Primary completion
Jan 8, 2029
Completion
Mar 1, 2029

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Green Tea Extract
  • Placebo Comparator: Placebo

Primary Outcome Measure

Change in neuropathic pain score [ Time Frame: Baseline, end of treatment (up to 16 weeks). ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294
Michael Daniel, PhD
[email protected]
205-975-0866
Michael Daniel, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Alabama at Birmingham· Birmingham, AL

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