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

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Alabama at Birmingham

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

    Rice flour

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Green Tea ExtractExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

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.

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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