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

• ClinicalTrials.gov Identifier: NCT04731844
• Recruitment Status: Recruiting
• First Posted: February 1, 2021
• Last Update Posted: July 14, 2023
• Sponsor: University of Rochester
• Information provided by (Responsible Party): Peter Van Veldhuizen, University of Rochester

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.

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.

Study Design

• 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, 2024
• Estimated Study Completion Date: May 31, 2024

Arms and Interventions

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®

Outcome Measures

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.

Eligibility Criteria

• 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.

Contacts and Locations

Contacts

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

Locations

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

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

More Information

• 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
• Last Update Posted: July 14, 2023
• Last Verified: June 2023

• 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:

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; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital 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