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

Launched by UNIVERSITY OF ROCHESTER · Jan 29, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at the effects of two natural supplements, curcumin and piperine, on patients with early-stage prostate cancer, or those with conditions like Monoclonal Gammopathy of Undetermined Significance (MGUS) or low-risk smoldering multiple myeloma (SMM) who are being monitored but not receiving treatment. The goal is to see if taking these supplements can help improve their health while they are on active surveillance. Participants will take 4 grams of curcumin and 5 milligrams of piperine twice a day for one year.

To join the study, participants need to be at least 18 years old and have either non-metastatic prostate cancer that they are monitoring, or MGUS or low-risk SMM without signs of serious complications. They should not be taking other supplements that contain curcumin or piperine and cannot plan to start any new treatments for their cancer during the trial. Throughout the study, participants will be closely monitored to ensure their safety and the effectiveness of the supplements. This is a unique opportunity for eligible patients to potentially benefit from natural supplements while being actively observed for their conditions.

Gender

ALL

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).
• • 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.