Daily, Encapsulated, Green Tea Extract to Mitigate Neuropathic Pain in Patients With Established Cancer-Associated Neuropathic Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Green Tea Leaf Extract Decaffeinated, Placebo Control.
- Who it may be relevant to
- Registry conditions: Neuropathic Pain, Cancer Treatment. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Daily, Encapsulated, Green Tea Extract (GTE) to Mitigate Neuropathic Pain in Patients With Established Cancer-Associated Neuropathic Pain
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.
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
Primary outcome measures
- Change in neuropathic pain score [Time frame: Baseline, end of treatment (up to 16 weeks).]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- University of Alabama at Birmingham — Birmingham
Identifiers
NCT: NCT07682324 · IRB-300016025 · UAB School of Nursing