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NCT Number: NCT07682324

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location contact

Michael Daniel, PhD

CONTACT

[email protected]

205-975-0866

Michael Daniel, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Sunphenon 90D

Placebo control

Other

Rice flour

Primary outcomes

  1. Change in neuropathic pain score

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Michael Daniel, PhD

CONTACT

[email protected]

205-975-0866

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

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

Acronym: GTE

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jul 2, 2026
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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