Green Tea, Quercetin + Chemotherapy for Prostate Cancer

Overseen By Piwen Wang, PhD

Age: 18+

Sex: Male

Trial Phase: Phase 1 & 2

Sponsor: Charles Drew University of Medicine and Science

Must be taking: Docetaxel, Prednisone

Disqualifiers: Chemotherapy, Radiotherapy, Alcohol abuse, others

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 9 weeks

99 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether adding green tea and quercetin (a plant pigment) to standard docetaxel chemotherapy can enhance treatment for advanced prostate cancer. Researchers aim to determine if these natural products can boost chemotherapy effectiveness and assess their safety. Participants will receive either the green tea and quercetin combination or a placebo alongside their chemotherapy. Men with advanced prostate cancer who are already undergoing medical or surgical castration may be suitable for this trial. Participants should avoid other tea and quercetin products during the study.

As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this novel combination.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but you must stop consuming tea or tea-containing products and quercetin supplements during the study, except for what is provided by the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

In past studies, researchers examined the effects of green tea and quercetin on prostate cancer. These natural compounds are usually well-tolerated. One study found that combining green tea and quercetin with chemotherapy significantly reduced tumor growth in prostate cancer models. However, researchers are still collecting safety data for humans.

Green tea and quercetin are popular supplements, and many people use them without major problems. Since this is an early-phase trial, researchers are closely studying the treatment's safety. Participants have not reported serious side effects so far, but monitoring for potential issues remains important.

Docetaxel, a chemotherapy drug approved by the FDA, is commonly used to treat various cancers, including prostate cancer. Like many chemotherapy drugs, it can have side effects. This trial aims to evaluate the safety and effectiveness of combining docetaxel with green tea and quercetin. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for prostate cancer?

Researchers are excited about the combination of green tea and quercetin with docetaxel for prostate cancer because it introduces natural compounds into the treatment process. Unlike standard prostate cancer therapies, which typically involve hormone therapy or chemotherapy alone, this approach uses green tea and quercetin, known for their antioxidant properties, to potentially enhance the effectiveness of docetaxel. The unique feature here is the synergy between these natural ingredients and the chemotherapy drug, which may offer a new mechanism to boost cancer-fighting effects while possibly reducing side effects. This innovative combination could pave the way for more effective and less toxic treatment options for patients.

What evidence suggests that green tea and quercetin might be an effective treatment for advanced prostate cancer?

This trial will evaluate the combination of green tea and quercetin with chemotherapy for prostate cancer. Studies have shown that green tea and quercetin can enhance the effectiveness of chemotherapy against prostate cancer. In one study, these natural products improved chemotherapy outcomes in mice with prostate cancer. Another study found that quercetin can help more green tea compounds reach the prostate, potentially aiding the body's fight against cancer. Early research also suggests that quercetin might inhibit the growth of prostate cancer cells. Together, these findings suggest that green tea and quercetin could enhance the effects of chemotherapy for advanced prostate cancer. Participants in this trial will receive either the green tea and quercetin combination with docetaxel or a placebo with docetaxel for comparison. ^{1 2 3 4 6}

Who Is on the Research Team?

Piwen Wang, PhD

Principal Investigator

Charles Drew University of Medicine and Science

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have been diagnosed with prostate cancer that has spread.

My cancer has worsened despite treatment with specific prostate cancer medications.

I am willing and able to follow the study rules and attend all required visits.

Exclusion Criteria

Ongoing alcohol abuse

Significant medical or psychiatric conditions that would make the patient a poor protocol candidate

I have received chemotherapy or radiotherapy for cancer that has spread.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive green tea and quercetin in combination with docetaxel chemotherapy or placebo for 3 cycles, each cycle lasting 21 days

9 weeks

3 visits (in-person) at the start of each cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Docetaxel
• Green Tea and Quercetin

Trial Overview 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.

How Is the Trial Designed?

Group I: green tea and quercetin Experimental Treatment 1 Intervention

Green tea and quercetin capsules will be administered in combination with docetaxel treatment.

Group II: placebo Placebo Group 1 Intervention

Placebo capsules will be administered in combination with docetaxel treatment as comparison.

Docetaxel is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Taxotere for:

• Breast Cancer
• Non-small Cell Lung Cancer
• Gastric Cancer
• Head and Neck Cancer
• Prostate Cancer

Approved in European Union as Taxotere for:

• Breast Cancer
• Non-small Cell Lung Cancer
• Gastric Cancer
• Head and Neck Cancer
• Prostate Cancer

Approved in Canada as Taxotere for:

• Breast Cancer
• Non-small Cell Lung Cancer
• Gastric Cancer
• Head and Neck Cancer
• Prostate Cancer

Approved in Japan as Taxotere for:

• Breast Cancer
• Non-small Cell Lung Cancer
• Gastric Cancer
• Head and Neck Cancer
• Prostate Cancer

Who Is Running the Clinical Trial?

Charles Drew University of Medicine and Science

Lead Sponsor

Trials

54

Recruited

8,500+

Watts Healthcare Corporation

Collaborator

Trials

1

Recruited

100+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT01912820

Effect of Quercetin on Green Tea Polyphenol Uptake in ... This randomized pilot phase I trial will evaluate if quercetin enhances the uptake of green tea polyphenols in the prostate tissue of men taking green tea ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8312236/

Prospective randomized trial evaluating blood and prostate ... We evaluated if chronic consumption of quercetin (Q) with green tea extract (GTE) enhances the bioavailability of GT polyphenols (GTPs) and reduces methylation ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S095528631300199X?via%3Dihub

Enhanced inhibition of prostate cancer xenograft tumor ... We determined whether a methylation inhibitor quercetin (Q) will enhance the chemoprevention of prostate cancer in vivo.

4. jeccr.biomedcentral.com jeccr.biomedcentral.com/articles/10.1186/s13046-016-0351-x

Green tea and quercetin sensitize PC-3 xenograft prostate ... This study investigated whether natural products green tea (GT) and quercetin (Q) enhance the therapeutic efficacy of Doc in CRPC in mouse models.

5. frontiersin.org frontiersin.org/journals/immunology/articles/10.3389/fimmu.2023.1077531/full

The potential anti-cancer effects of quercetin on blood, ... This review aims to highlight the potential therapeutic effects of quercetin on some different types of cancers including blood, lung and prostate cancers.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06615752

Study Details | NCT06615752 | Green Tea and Quercetin ... The goal of this clinical trial is to find out if taking natural products green tea and quercetin along with docetaxel chemotherapy improves the therapy of ...