Curcumin and Piperine in Patients on Surveillance for Monoclonal Gammopathy, Smoldering Myeloma or Prostate Cancer
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
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 prostate-cancer
Started Dec 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 26, 2021
CompletedFirst Posted
Study publicly available on registry
February 1, 2021
CompletedStudy Start
First participant enrolled
December 14, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2025
CompletedJuly 12, 2024
July 1, 2024
3.5 years
January 26, 2021
July 10, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
From date of enrollment until the date of first documented response assessed up to 12 months
Secondary Outcomes (1)
Progression Free Survival
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
Study Arms (3)
Prostate Cancer
EXPERIMENTALCurcumin plus Piperine at a dose of 4 gram/5mg orally BID for 12 months
Smoldering Multiple Myeloma (SMM)
EXPERIMENTALCurcumin plus Piperine at a dose of 4 gram/5mg orally BID for 12 months
Monoclonal Gammopathy of Unknown Significance (MGUS)
EXPERIMENTALCurcumin plus Piperine at a dose of 4 gram/5mg orally BID for 12 months
Interventions
Curcumin with piperine is a well-tolerated over-the-counter supplement.
Eligibility Criteria
You may qualify if:
- 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.
- +2 more criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Rochester
Rochester, New York, 14623, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Brea Lipe
University of Rochester Wilmot Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor - Department of Medicine , Hematology/Oncology (SMD)
Study Record Dates
First Submitted
January 26, 2021
First Posted
February 1, 2021
Study Start
December 14, 2021
Primary Completion
May 31, 2025
Study Completion
May 31, 2025
Last Updated
July 12, 2024
Record last verified: 2024-07