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Chemotherapy
Green Tea, Quercetin + Chemotherapy for Prostate Cancer
Phase 1 & 2
Waitlist Available
Led By Piwen Wang, PhD
Research Sponsored by Charles Drew University of Medicine and Science
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Confirmed progressive disease with concurrent use of enzalutamide, apalutamide, darolutamide, and/or abiraterone acetate
Adequate bone marrow function (ANC more than 1500 cells/mm³, platelet count more than 100,000 cells/mm³)
Must not have
Any comorbid condition that would preclude the administration of docetaxel/prednisone
Prior treatment of chemotherapy and/or radiotherapy for metastatic disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up on the 1st day of cycle 1 (each cycle is 21 days, 3 cycles total) of the dose escalation study.
Summary
This trial aims to see if adding green tea and quercetin to standard chemotherapy can help in treating advanced prostate cancer. Researchers will compare this combination to a placebo to understand its effectiveness and safety.
Who is the study for?
This trial is for men with advanced prostate cancer that continues to grow despite hormone therapy. Participants must have metastatic castration-resistant prostate cancer and be suitable for docetaxel chemotherapy. Specific eligibility details are not provided, but typically include factors like age, health status, and prior treatments.
What is being tested?
The study tests if green tea and quercetin can boost the effectiveness of docetaxel chemotherapy in treating advanced prostate cancer. Patients will either receive a placebo or the natural product combination alongside their standard chemotherapy regimen.
What are the potential side effects?
While specific side effects aren't listed here, common ones from docetaxel include fatigue, nausea, hair loss, low blood cell counts increasing infection risk; green tea and quercetin may add minimal side effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has worsened despite treatment with specific prostate cancer medications.
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My blood tests show my bone marrow is working well.
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I am willing to stop drinking tea and taking quercetin supplements except for those provided in the study.
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My cancer progressed despite hormone therapy or surgery to lower hormones.
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My liver function tests are within normal limits.
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I am a man aged 18 or older.
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I have been diagnosed with prostate cancer that has spread.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have any health conditions that would prevent me from taking docetaxel/prednisone.
Select...
I have received chemotherapy or radiotherapy for cancer that has spread.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ on the 1st day of cycle 1 (each cycle is 21 days, 3 cycles total) of the dose escalation study.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~on the 1st day of cycle 1 (each cycle is 21 days, 3 cycles total) of the dose escalation study.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Efficacy evaluated with blood prostate specific antigen (PSA) level
Secondary study objectives
Adverse events graded by using NCI CTCAE criteria
Area under curve (AUC) of blood green tea, quercetin, and docetaxel
Maximum concentrations (Cmax) of blood green tea, quercetin, and docetaxel
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: green tea and quercetinExperimental Treatment1 Intervention
Green tea and quercetin capsules will be administered in combination with docetaxel treatment.
Group II: placeboPlacebo Group1 Intervention
Placebo capsules will be administered in combination with docetaxel treatment as comparison.
Find a Location
Who is running the clinical trial?
Watts Healthcare CorporationUNKNOWN
National Institute on Minority Health and Health Disparities (NIMHD)NIH
432 Previous Clinical Trials
1,377,692 Total Patients Enrolled
5 Trials studying Prostate Cancer
2,130 Patients Enrolled for Prostate Cancer
Charles Drew University of Medicine and ScienceLead Sponsor
52 Previous Clinical Trials
6,604 Total Patients Enrolled
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