Green Tea and Quercetin in Combination With Docetaxel Chemotherapy in Castration-resistant Prostate Cancer Patients

Launched by CHARLES DREW UNIVERSITY OF MEDICINE AND SCIENCE · Sep 24, 2024

Keywords

ClinConnect Summary

This clinical trial is studying whether adding natural substances—green tea and quercetin (a plant antioxidant)—to a common chemotherapy drug called docetaxel can help men with advanced prostate cancer that no longer responds to hormone treatment. The main goals are to see if this combination works better than chemotherapy alone and to check if it is safe to use. Participants will receive either green tea and quercetin or a placebo (a harmless, inactive substance) along with their chemotherapy to compare the effects.

Men who are 18 years or older with metastatic prostate cancer that is progressing despite hormone treatments may be eligible to join. They must be about to start docetaxel chemotherapy with prednisone, have good blood, liver, and kidney function, and expect to live at least six months. Participants will need to agree to stop drinking tea or taking quercetin supplements on their own during the study, except for what the study provides. People who have had chemotherapy before for metastatic disease, have serious health issues, or allergies to tea or quercetin won’t be able to join. This study is currently recruiting patients and aims to find new ways to improve treatment for this challenging stage of prostate cancer.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Signed and dated informed consent form and HIPPA (Health Insurance Portability and Accountability Act) authorization.
• • 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:
• • Prior treatment of chemotherapy and/or radiotherapy for metastatic disease
• • 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