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Turmeric + Metformin for Prostate Cancer

Phase 1

Recruiting

Led By Shi-Ming Tu, MD

Research Sponsored by University of Arkansas

Eligibility Criteria Checklist

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

Must have

History of prior prostatectomy and/or radiation therapy to the prostate

Eugonad with testosterone > 150 ng/dl at time of consent

Must not have

Any active or deteriorating liver or renal disease, Human Immunodeficiency Virus (HIV), Hepatitis B, Hepatitis C or bone marrow deficiency

Any history of allergic reactions attributed to turmeric, metformin, or other compounds of similar chemical or biologic compositions

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 27 months

Awards & highlights

No Placebo-Only Group

Summary

This trial assesses adding Metformin and turmeric to current care for prostate cancer patients to see if it helps. Participants will take pills, have blood & stool samples taken and complete questionnaires.

Who is the study for?

Men over 18 with prostate cancer who've had surgery or radiation, currently have rising PSA levels, and are on intermittent Androgen Deprivation Therapy (iADT). They must not have other active cancers or severe liver/renal disease, HIV, Hepatitis B/C, bone marrow issues, history of allergic reactions to turmeric/metformin, or risk factors for lactic acidosis.

What is being tested?

The trial is testing the addition of metformin and turmeric to standard iADT in men with castration sensitive prostate cancer showing biochemical progression. It aims to see if this nutritional intervention affects the time until PSA levels rise again.

What are the potential side effects?

Potential side effects may include digestive issues due to turmeric and metformin such as nausea or diarrhea. Metformin can also cause a rare but serious condition called lactic acidosis especially in people with kidney problems.

Eligibility Criteria

Inclusion Criteria

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

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I have had surgery or radiation for prostate cancer.

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My testosterone levels are above 150 ng/dl.

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I am fully active or can carry out light work.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have active liver, kidney disease, HIV, Hepatitis B/C, or bone marrow issues.

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I am allergic to turmeric, metformin, or similar substances.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 27 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 27 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 27 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Assess feasibility of recruitment

Evaluate time to PSA relapse with nutritional intervention on iADT.

Secondary study objectives

Quality of Life (QOL) assessed by the Aging Male Symptoms Questionnaire (AMS Questionnaire).

Quality of life (QOL) assessed by the Functional Assessment of Cancer Therapy-Prostate (FACT-P), Version 4.

Other study objectives

Expression levels of CSC biomarkers including EMT and miRNAS from blood samples

Expression levels of Cancer dormancy Biomarkers (miR-200s, TGF-beta, BMPs, immune and inflammatory factors) from blood samples

Expression levels of Metabolomic biomarkers from blood samples

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Metformin + TurmericExperimental Treatment2 Interventions

Each subject will begin using metformin and turmeric within 7 days of consent. Subjects will start with metformin 500 mg by mouth (po) two times daily (bid) with meals for 14 days. Metformin titration will then increase to 850 milligram (mg) po bid for 14 days before increasing titration to a desired dosage of 1,000 mg po bid. For those subjects currently taking Metformin, they will continue current dose (if 1,000 mg po bid) or titrate dose as just described until maximum dose is achieved. After two weeks of metformin titration, each subject will start with 1,500 mg turmeric po daily with meals. Dose can be temporarily reduced to 1,000 mg po daily for those who report GI discomfort. If GI discomfort has resolved within one month of the dose reduction, subjects will resume 1,500 mg po daily. If GI discomfort has not resolved the participant may be insturcted to stop taking the study treatment and be removed from the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Turmeric

2011

Completed Phase 3

~480

Metformin

2006

Completed Phase 4

~2430