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

July 13, 2023 updated by: Peter Van Veldhuizen, University of Rochester

Efficacy of Curcumin and Piperine in Patients on Active Surveillance for Either Monoclonal Gammopathy of Unknown Significance (MGUS), Low-risk Smoldering Multiple Myeloma (SMM) or Early Stage Prostate Cancer: A Pilot Study

To explore the use of curcumin and piperine supplementation at a dose of 4 gram/5mg twice a day in early stage prostate cancer patient undergoing active surveillance or patients on observation for MGUS/ low-risk smoldering myeloma.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to determine whether the supplement of curcumin plus peperine can prevent or delay the progression of prostate cancer, monoclonal gammopathy of unknown significant, or low-risk smoldering myeloma into a more aggressive cancer which requires treatment. The investigator will be evaluating a marker in patients blood called MIC-1 to determine whether it could be a useful predictor of whether the disease is improving or progressing.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • The patient or a legally authorized representative must provide study-specific informed consent prior to study entry.
  • Age ≥ 18 years of age.
  • Karnofsky performance status (KPS) of ≥ 70%.
  • Subjects with either 1) non-metastatic biopsy proven adenocarcinoma of the prostate who have chosen AS the treatment option for their prostate cancer or 2) have the diagnosis of either MGUS or low-risk SMM and are currently on observation alone.

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

    1. MGUS: serum M-protein <3.0g/dL, <10% clonal plasma cells (PCs) in the bone marrow, and absence of end-organ damage (CRAB criteria) that can be attributed to the plasma cell disorder.

    2. SMM: serum M-protein of ≥3.0g/dL or a proportion of clonal PCs in the BM of ≥10% but <60%, and no evidence of end organ damage as described below.

      • Absence of end organ damage is defined by absence of CRAB criteria:

        • C: Absence of hypercalcemia, defined as calcium ≤11mg/dL.
        • R: Absence of renal failure, defined as serum creatinine ≤2.0mg/dL.
        • A: Absence of anemia, defined as hemoglobin ≥10g/dL.
        • B: Absence of lytic bone lesions per IMWG recommendations: One of either PET-CT, low-dose whole-body CT, or whole- body MRI. Increased uptake on PET-CT alone is not adequate for the diagnosis of multiple myeloma; evidence of underlying osteolytic bone destruction is needed on the CT portion of the examination.

  • At least one of the risk factors below that portends for an increased risk of progression to 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.

Exclusion Criteria

  • Currently taking supplements containing either curcumin or piperine.
  • Plan to start any additional over the counter supplements prior to or during trial period.
  • For prostate cancer patients must not be planning to undergoing primary curative therapy for their prostate cancer (radiation, surgery, brachytherapy).
  • For MGUS/ SMM patients, must not have had evidence of disease progression which might require treatment during the one-year study period.
  • Other: symptomatic plasma cell leukemia, amyloidosis, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein).
  • Subject is pregnant or breast feeding, or planning to become pregnant during the treatment period.
  • Evidence of any of the following conditions per subject self-report or medical chart review: Major surgery or significant traumatic injury occurring within 4 weeks before enrollment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prostate Cancer
Curcumin plus Piperine at a dose of 4 gram/5mg orally BID for 12 months
Drug: Curcumin plus Piperine
Curcumin with piperine is a well-tolerated over-the-counter supplement.
Other Names:
  • Curcumin C3 Complex®
Experimental: Smoldering Multiple Myeloma (SMM)
Curcumin plus Piperine at a dose of 4 gram/5mg orally BID for 12 months
Drug: Curcumin plus Piperine
Curcumin with piperine is a well-tolerated over-the-counter supplement.
Other Names:
  • Curcumin C3 Complex®
Experimental: Monoclonal Gammopathy of Unknown Significance (MGUS)
Curcumin plus Piperine at a dose of 4 gram/5mg orally BID for 12 months
Drug: Curcumin plus Piperine
Curcumin with piperine is a well-tolerated over-the-counter supplement.
Other Names:
  • Curcumin C3 Complex®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response rate of Curcumin & Piperine supplementation in patients on AS for either early stage prostate cancer or MGUS.
Time Frame: From date of enrollment until the date of first documented response assessed up to 12 months
Measure of time from study enrollment until response
From date of enrollment until the date of first documented response assessed up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival
Time Frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Measure of time from study enrollment until progression.
From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester

Investigators

  • Principal Investigator: Peter Van Veldhuizen, University of Rochester Wilmot Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 14, 2021

Primary Completion (Estimated)

May 31, 2024

Study Completion (Estimated)

May 31, 2024

Study Registration Dates

First Submitted

January 26, 2021

First Submitted That Met QC Criteria

January 29, 2021

First Posted (Actual)

February 1, 2021

Study Record Updates

Last Update Posted (Actual)

July 14, 2023

Last Update Submitted That Met QC Criteria

July 13, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UMLT20123

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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