Clinical Trials /

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

NCT04731844

Description:

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.

Related Conditions:
  • Prostate Adenocarcinoma
  • Smoldering Plasma Cell Myeloma
Recruiting Status:

Not yet recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Curcumin and Piperine in Patients on Surveillance for Monoclonal Gammopathy, Smoldering Myeloma or Prostate Cancer
  • Official Title: 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

Clinical Trial IDs

  • ORG STUDY ID: UMLT20123
  • NCT ID: NCT04731844

Conditions

  • Prostate Cancer
  • Multiple Myeloma
  • Smoldering Multiple Myeloma (SMM)
  • Monoclonal Gammopathy of Undetermined Significance

Interventions

DrugSynonymsArms
Curcumin plus PiperineCurcumin C3 Complex®Monoclonal Gammopathy of Unknown Significance (MGUS)

Purpose

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.

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.
    

Trial Arms

NameTypeDescriptionInterventions
Prostate CancerExperimentalCurcumin plus Piperine at a dose of 4 gram/5mg orally BID for 12 months
  • Curcumin plus Piperine
Smoldering Multiple Myeloma (SMM)ExperimentalCurcumin plus Piperine at a dose of 4 gram/5mg orally BID for 12 months
  • Curcumin plus Piperine
Monoclonal Gammopathy of Unknown Significance (MGUS)ExperimentalCurcumin plus Piperine at a dose of 4 gram/5mg orally BID for 12 months
  • Curcumin plus Piperine

Eligibility Criteria

        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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure: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
Safety Issue:
Description:Measure of time from study enrollment until response

Secondary Outcome Measures

Measure: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
Safety Issue:
Description:Measure of time from study enrollment until progression.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:University of Rochester

Trial Keywords

  • curcumin
  • peperine
  • prostate cancer
  • Multiple Myeloma
  • Smoldering Multiple Myeloma (SMM)
  • Monoclonal Gammopathy of Undetermined Significance (MGUS)

Last Updated

June 9, 2021