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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04731844
Recruitment Status : Recruiting
First Posted : February 1, 2021
Last Update Posted : June 21, 2022
Sponsor:
Information provided by (Responsible Party):
Peter Van Veldhuizen, University of Rochester

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Multiple Myeloma Smoldering Multiple Myeloma (SMM) Monoclonal Gammopathy of Undetermined Significance Drug: Curcumin plus Piperine Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 14, 2021
Estimated Primary Completion Date : May 31, 2023
Estimated Study Completion Date : May 31, 2023


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 Name: 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 Name: 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 Name: Curcumin C3 Complex®




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04731844


Contacts
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Contact: Peter Van Veldhuizen (585) 275-3746 Peter_Vanveldhuizen@URMC.Rochester.edu

Locations
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United States, New York
University of Rochester Recruiting
Rochester, New York, United States, 14623
Contact: Peter Van Veldhuizen    585-275-3746    Peter_Vanveldhuizen@URMC.Rochester.edu   
Principal Investigator: Peter Van Veldhuizen, MD         
Sponsors and Collaborators
University of Rochester
Investigators
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Principal Investigator: Peter Van Veldhuizen University of Rochester Wilmot Cancer Center
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Responsible Party: Peter Van Veldhuizen, Professor - Department of Medicine , Hematology/Oncology (SMD), University of Rochester
ClinicalTrials.gov Identifier: NCT04731844    
Other Study ID Numbers: UMLT20123
First Posted: February 1, 2021    Key Record Dates
Last Update Posted: June 21, 2022
Last Verified: February 2022

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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
Keywords provided by Peter Van Veldhuizen, University of Rochester:
curcumin
peperine
prostate cancer
Multiple Myeloma
Smoldering Multiple Myeloma (SMM)
Monoclonal Gammopathy of Undetermined Significance (MGUS)
Additional relevant MeSH terms:
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Prostatic Neoplasms
Multiple Myeloma
Neoplasms, Plasma Cell
Smoldering Multiple Myeloma
Paraproteinemias
Monoclonal Gammopathy of Undetermined Significance
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Hypergammaglobulinemia
Precancerous Conditions
Curcumin
Piperine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents