RECRUITING

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

Conditions

Prostate Cancer Multiple Myeloma Smoldering Multiple Myeloma (SMM)Monoclonal Gammopathy of Undetermined Significance curcumin peperine Monoclonal Gammopathy of Undetermined Significance (MGUS)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood 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.

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

Quick Facts

Study Start:2021-12-14

Study Completion:2025-05-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04731844

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	Pregnancy or breastfeeding Severe psychiatric disorders Active substance abuse Unstable medical conditions Inability to comply with study requirements

Inclusion Criteria

Exclusion 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.

Pregnancy or breastfeeding
Severe psychiatric disorders
Active substance abuse
Unstable medical conditions
Inability to comply with study requirements

Contacts and Locations

Study Contact

Brea Lipe

CONTACT

(585) 273-1276

Brea_Lipe@URMC.Rochester.edu

Principal Investigator

Brea Lipe

PRINCIPAL_INVESTIGATOR

University of Rochester Wilmot Cancer Center

Study Locations (Sites)

University of Rochester

Rochester, New York, 14623

United States

Collaborators and Investigators

Sponsor: University of Rochester

Brea Lipe, PRINCIPAL_INVESTIGATOR, University of Rochester Wilmot Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-12-14

Study Completion Date2025-05-31

Study Record Updates

Study Start Date2021-12-14

Study Completion Date2025-05-31

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

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