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

Primary Purpose

Prostate Cancer, Multiple Myeloma, Smoldering Multiple Myeloma (SMM)

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Curcumin plus Piperine
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring curcumin, peperine, prostate cancer, Multiple Myeloma, Smoldering Multiple Myeloma (SMM), Monoclonal Gammopathy of Undetermined Significance (MGUS)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of RochesterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Prostate Cancer

Smoldering Multiple Myeloma (SMM)

Monoclonal Gammopathy of Unknown Significance (MGUS)

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Response rate of Curcumin & Piperine supplementation in patients on AS for either early stage prostate cancer or MGUS.
Measure of time from study enrollment until response

Secondary Outcome Measures

Progression Free Survival
Measure of time from study enrollment until progression.

Full Information

First Posted
January 26, 2021
Last Updated
July 13, 2023
Sponsor
University of Rochester
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1. Study Identification

Unique Protocol Identification Number
NCT04731844
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 14, 2021 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Multiple Myeloma, Smoldering Multiple Myeloma (SMM), Monoclonal Gammopathy of Undetermined Significance
Keywords
curcumin, peperine, prostate cancer, Multiple Myeloma, Smoldering Multiple Myeloma (SMM), Monoclonal Gammopathy of Undetermined Significance (MGUS)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Prostate Cancer
Arm Type
Experimental
Arm Description
Curcumin plus Piperine at a dose of 4 gram/5mg orally BID for 12 months
Arm Title
Smoldering Multiple Myeloma (SMM)
Arm Type
Experimental
Arm Description
Curcumin plus Piperine at a dose of 4 gram/5mg orally BID for 12 months
Arm Title
Monoclonal Gammopathy of Unknown Significance (MGUS)
Arm Type
Experimental
Arm Description
Curcumin plus Piperine at a dose of 4 gram/5mg orally BID for 12 months
Intervention Type
Drug
Intervention Name(s)
Curcumin plus Piperine
Other Intervention Name(s)
Curcumin C3 Complex®
Intervention Description
Curcumin with piperine is a well-tolerated over-the-counter supplement.
Primary Outcome Measure Information:
Title
Response rate of Curcumin & Piperine supplementation in patients on AS for either early stage prostate cancer or MGUS.
Description
Measure of time from study enrollment until response
Time Frame
From date of enrollment until the date of first documented response assessed up to 12 months
Secondary Outcome Measure Information:
Title
Progression Free Survival
Description
Measure of time from study enrollment until progression.
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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). 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. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peter Van Veldhuizen
Phone
(585) 275-3746
Email
Peter_Vanveldhuizen@URMC.Rochester.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Van Veldhuizen
Organizational Affiliation
University of Rochester Wilmot Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Van Veldhuizen
Phone
585-275-3746
Email
Peter_Vanveldhuizen@URMC.Rochester.edu
First Name & Middle Initial & Last Name & Degree
Peter Van Veldhuizen, MD

12. IPD Sharing Statement

Learn more about this trial

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

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