RECRUITING

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

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.

Study Overview

Study Details

Study overview

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.

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

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

Condition
Prostate Cancer
Intervention / Treatment

-

Contacts and Locations

Rochester

University of Rochester, Rochester, New York, United States, 14623

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Rochester,

Brea Lipe, PRINCIPAL_INVESTIGATOR, University of Rochester Wilmot Cancer Center

Study Record Dates

2025-05-31