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Curcumin + Piperine for Prostate Cancer

Phase 2

Recruiting

Led By Peter Van Veldhuizen

Research Sponsored by University of Rochester

Eligibility Criteria Checklist

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

Must have

For patients with MGUS or low-risk SMM, diagnosis must be according to the definition of the International Myeloma Working Group (IMWG).

At least one of the risk factors below that portends for an increased risk of progression to Multiple Myeloma (MM): Abnormal serum free light chain ratio, M-spike ≥2.0g/dL, ≥ 20% bone marrow clonal plasma cells, Immunoparesis ≥20% reduction from institutional normal standard of uninvolved immunoglobulins.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of enrollment until the date of first documented response assessed up to 12 months

Awards & highlights

Study Summary

This trial will explore the use of curcumin and piperine supplementation to treat early stage prostate cancer and myeloma.

Who is the study for?

This trial is for adults over 18 with early-stage prostate cancer opting for active surveillance, or those with Monoclonal Gammopathy of Undetermined Significance (MGUS) or low-risk Smoldering Multiple Myeloma (SMM) not requiring treatment. Participants must have certain risk factors indicating progression to MM and be in good physical condition. Pregnant individuals, recent surgery patients, and those taking curcumin or piperine supplements are excluded.Check my eligibility

What is being tested?

The study tests the effects of a daily dose of curcumin (4 grams) combined with piperine (5 mg), taken twice a day by patients under observation for MGUS/low-risk SMM or early-stage prostate cancer on active surveillance. The goal is to see if these supplements can benefit patients at these stages.See study design

What are the potential side effects?

While specific side effects aren't listed here, common ones associated with curcumin and piperine may include digestive discomfort such as nausea, diarrhea, gas, bloating; skin rash; and headache. These are generally considered safe but should be monitored.

Eligibility Criteria

Inclusion Criteria

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

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My MGUS or SMM diagnosis follows international expert guidelines.

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I have at least one risk factor indicating a high chance of my condition progressing to Multiple Myeloma.

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I am 18 years old or older.

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I am able to care for myself but may not be able to do active work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of enrollment until the date of first documented response assessed up to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of enrollment until the date of first documented response assessed up to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of enrollment until the date of first documented response assessed up to 12 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

Response rate of Curcumin & Piperine supplementation in patients on AS for either early stage prostate cancer or MGUS.

Secondary outcome measures

Progression Free Survival

Trial Design

3Treatment groups

Experimental Treatment

Group I: Smoldering Multiple Myeloma (SMM)Experimental Treatment1 Intervention

Curcumin plus Piperine at a dose of 4 gram/5mg orally BID for 12 months

Group II: Prostate CancerExperimental Treatment1 Intervention

Curcumin plus Piperine at a dose of 4 gram/5mg orally BID for 12 months

Group III: Monoclonal Gammopathy of Unknown Significance (MGUS)Experimental Treatment1 Intervention

Curcumin plus Piperine at a dose of 4 gram/5mg orally BID for 12 months

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of RochesterLead Sponsor

840 Previous Clinical Trials

534,210 Total Patients Enrolled

7 Trials studying Prostate Cancer

517 Patients Enrolled for Prostate Cancer

Peter Van VeldhuizenPrincipal InvestigatorUniversity of Rochester Wilmot Cancer Center

1 Previous Clinical Trials

97 Total Patients Enrolled

Media Library

Curcumin plus Piperine Clinical Trial Eligibility Overview. Trial Name: NCT04731844 — Phase 2

Prostate Cancer Research Study Groups: Prostate Cancer, Smoldering Multiple Myeloma (SMM), Monoclonal Gammopathy of Unknown Significance (MGUS)

Prostate Cancer Clinical Trial 2023: Curcumin plus Piperine Highlights & Side Effects. Trial Name: NCT04731844 — Phase 2

Curcumin plus Piperine 2023 Treatment Timeline for Medical Study. Trial Name: NCT04731844 — 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 does the trial have capacity to accomodate?

"Affirmative, clinicaltrials.gov lists this trial as actively enrolling patients. It was first shared on December 14th 2021 and the most up to date information is from June 17th 2022. 40 individuals are being sought out by 1 medical centre for participation in the study."

Answered by AI

Is there any prior research to support the utilization of Curcumin plus Piperine in experimental studies?

"At the present, 17 clinical trials encompassing Curcumin plus Piperine are being conducted. Of these studies, 3 are in their final phase of testing. Although Farmington Hills is the primary location for this research, there are 21 other sites around Michigan hosting tests related to this treatment."

Answered by AI

Is the combination of Curcumin and Piperine a safe option for treating patients?

"Our assessment of Curcumin plus Piperine's safety was a 2, since there is evidence that it does not pose significant risks; however, this Phase 2 trial has yet to reveal any efficacy data."

Answered by AI

Is this trial currently recruiting participants?

"Correct. Clinicaltrials.gov displays that this research endeavor, which was first made available on December 14th 2021, is actively recruiting volunteers. 40 participants must be sought from one medical site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Curcumin and Piperine in Patients on Surveillance for Monoclonal Gammopathy, Smoldering Myeloma or Prostate Cancer

Peter Van Veldhuizen 2021. "Curcumin and Piperine in Patients on Surveillance for Monoclonal Gammopathy, Smoldering Myeloma or Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04731844.

All > Prostate Cancer