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Green Tea Extract for Prostate Cancer

Q: How many participants are being allowed to join this experiment?

That is correct, the information on clinicaltrials.gov currently says that this study is still looking for patients to enroll. The trial was originally posted on 8/21/2020 and has been edited as recently as 9/30/2022. So far, 135 patients have enrolled at the 1 location.

Q: Has Sunphenon been cleared by the FDA?

Sunphenon has received a safety score of 2. This is due to the fact that it is only in Phase 2, meaning while there is some evidence supporting its safety, there is no data affirming its effectiveness.

Q: What are some of the issues that Sunphenon has been shown to be effective in treating?

Sunphenon is most commonly used to help patients who are not immunocompromised. Additionally, this medication can be taken as a treatment for other conditions like <a href="https://www.withpower.com/clinical-trials/weight-loss">weight loss</a>, condylomata acuminata, and reducing <a href="https://www.withpower.com/clinical-trials/diet">diet</a>.

Q: Are new volunteers being accepted for this research project?

Yes, you are correct. The clinical trial is still recruiting patients and was last updated on 9/30/2022. It began enrolling participants on 8/21/2020 at a single medical centre but needs 135 total subjects.

Phase 2

Recruiting

Led By Nagi Kumar, PhD, RD, FADA

Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 years or older

Gleason score (3+3) or predominant Gleason pattern 3 (3+4)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

Study Summary

This trial will evaluate the safety, effectiveness and bioavailability of a standardized Green Tea Catechin formulation given over 24 months to men with low- to intermediate-grade prostate managed on active surveillance.

Who is the study for?

Men 18 or older with low to intermediate grade prostate cancer managed on active surveillance can join. They must have a PSA <10 ng/mL, no history of serious kidney or liver disease, and agree to limit tea intake and not use other vitamin/mineral supplements during the trial. Prior treatments for prostate cancer or recent use of certain medications disqualify participation.Check my eligibility

What is being tested?

The study is testing Sunphenon (a green tea extract) against a placebo over two years to see if it's safe and effective in men with prostate cancer who are being closely monitored but not actively treated. The trial randomly assigns participants to either the supplement or placebo group without them knowing which one they're getting.See study design

What are the potential side effects?

While specific side effects aren't listed, potential reactions could include those commonly associated with dietary supplements such as digestive discomfort, allergic reactions for those sensitive to tea components, and possible interactions with other medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

Select...

My prostate cancer has a Gleason score of 3+3 or 3+4.

Select...

I am willing to stop my current vitamins and use those provided by the study.

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My prostate cancer was confirmed by a biopsy.

Select...

I have not received any treatment for prostate cancer before.

Select...

I am fully active or can carry out light work.

Select...

I have no history of kidney or liver diseases, including hepatitis B or C.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Rate of Progression to Prostate Cancer (PCa)

Secondary outcome measures

Acceptability of Green Tea Catechins vs.Placebo

Adherence of Green Tea Catechins vs.Placebo

Change in (prostate-specific antigen) PSA and PSA kinetics

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Sunphenon® 90DExperimental Treatment1 Intervention

Participants will be administered a standardized formulation of whole Green Tea Catechin for 24 months. The daily dose of Green Tea Catechin will be taken in divided doses, three capsules in the morning and 3 capsules in the evening, with food (within one hour of eating a substantial meal). On the day of monthly follow-up visit, capsules should be taken within 4 hours of visit and blood draw for required lab work. If the participant is scheduled to come in the afternoon, dose should be taken with lunch that day instead of with dinner for that day.

Group II: PlaceboPlacebo Group1 Intervention

Participants will be administered a placebo for 24 months. The daily dose of placebo will be taken in divided doses, three capsules in the morning and 3 capsules in the evening, with food (within one hour of eating a substantial meal). On the day of monthly follow-up visit, capsules should be taken within 4 hours of visit and blood draw for required lab work. If the participant is scheduled to come in the afternoon, dose should be taken with lunch that day instead of with dinner for that day.

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor

542 Previous Clinical Trials

135,357 Total Patients Enrolled

27 Trials studying Prostate Cancer

4,049 Patients Enrolled for Prostate Cancer

National Cancer Institute (NCI)NIH

13,663 Previous Clinical Trials

40,925,770 Total Patients Enrolled

560 Trials studying Prostate Cancer

506,960 Patients Enrolled for Prostate Cancer

Nagi Kumar, PhD, RD, FADAPrincipal InvestigatorMoffitt Cancer Center

Media Library

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT04300855 — Phase 2

Prostate Cancer Research Study Groups: Sunphenon® 90D, Placebo

Prostate Cancer Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT04300855 — Phase 2

Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT04300855 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are being allowed to join this experiment?

"That is correct, the information on clinicaltrials.gov currently says that this study is still looking for patients to enroll. The trial was originally posted on 8/21/2020 and has been edited as recently as 9/30/2022. So far, 135 patients have enrolled at the 1 location."

Answered by AI

Has Sunphenon been cleared by the FDA?

"Sunphenon has received a safety score of 2. This is due to the fact that it is only in Phase 2, meaning while there is some evidence supporting its safety, there is no data affirming its effectiveness."

Answered by AI

What are some of the issues that Sunphenon has been shown to be effective in treating?

"Sunphenon is most commonly used to help patients who are not immunocompromised. Additionally, this medication can be taken as a treatment for other conditions like weight loss, condylomata acuminata, and reducing diet."

Answered by AI

Are new volunteers being accepted for this research project?

"Yes, you are correct. The clinical trial is still recruiting patients and was last updated on 9/30/2022. It began enrolling participants on 8/21/2020 at a single medical centre but needs 135 total subjects."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Clinical Trial of Green Tea Catechins in Men on Active Surveillance

2020. "Clinical Trial of Green Tea Catechins in Men on Active Surveillance". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04300855.

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