Green Tea and Quercetin in Combination With Docetaxel Chemotherapy in Castration-resistant Prostate Cancer Patients
NCT ID: NCT06615752
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
99 participants
INTERVENTIONAL
2026-03-31
2029-02-28
Brief Summary
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Researchers will compare green tea plus quercetin to a placebo (a look-alike substance that contains no drug) in combination with docetaxel to see if green tea and quercetin works to improve the therapeutic effect of docetaxel.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
QUADRUPLE
Study Groups
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green tea and quercetin
Green tea and quercetin capsules will be administered in combination with docetaxel treatment.
green tea and quercetin + docetaxel
green tea and quercetin supplements in combination with docetaxel infusion
placebo
Placebo capsules will be administered in combination with docetaxel treatment as comparison.
Placebo + docetaxel
Placebo will be given along with docetaxel chemotherapy
Interventions
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green tea and quercetin + docetaxel
green tea and quercetin supplements in combination with docetaxel infusion
Placebo + docetaxel
Placebo will be given along with docetaxel chemotherapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Stated willingness to comply with all study procedures and availability for the duration of the study.
* Male patients 18 years or older
* Diagnosed with metastatic prostate cancer
* History of confirmed progressive disease with concurrent use of medical castration (e.g. luteinizing hormone-releasing hormone analogue), or surgical castration
* Confirmed progressive disease with concurrent use of enzalutamide, apalutamide, darolutamide, and/or abiraterone acetate
* Clinical decision to start doc infusion with prednisone treatment
* Adequate bone marrow function (absolute neutrophil count (ANC) more than1500 cells/mm³, platelet count more than 100,000 cells/mm³)
* Adequate liver function (total bilirubin less than upper limit of normal (ULN), alanine aminotransferase (ALT) less than 1.5 x ULN, aspartate aminotransferase (AST) less than 1.5 x ULN)
* Adequate renal function (serum creatinine level within normal limits)
* At least a 6-month or greater life expectancy
* Willing to stop consuming tea or tea-containing products and quercetin supplements throughout the entire intervention period except for the green tea extract and quercetin provided during study intervention
Exclusion Criteria
* Any comorbid condition that would preclude the administration of docetaxel/prednisone
* Ongoing alcohol abuse
* Significant medical or psychiatric conditions that would make the patient a poor protocol candidate
* Prior allergic reaction to tea, tea products or quercetin supplements
* Allergies to multiple food items or nutritional supplements
18 Years
MALE
No
Sponsors
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National Institute on Minority Health and Health Disparities (NIMHD)
NIH
Watts Healthcare Corporation
UNKNOWN
Charles Drew University of Medicine and Science
OTHER
Responsible Party
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Piwen Wang
Associate Professor
Principal Investigators
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Piwen Wang, PhD
Role: PRINCIPAL_INVESTIGATOR
Charles Drew University of Medicine and Science
Locations
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Charles R. Drew University of Medicine and Science
Los Angeles, California, United States
Countries
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Central Contacts
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Facility Contacts
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Piwen Wang, PhD
Role: primary
Other Identifiers
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2188250-3
Identifier Type: -
Identifier Source: org_study_id