NCT04731844 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2026-05-12

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Response Rate of Curcumin & Piperine Supplementation in Patients on Active Surveillance for Either Early Stage Prostate Cancer or Patients on Observation for MGUS/Low-risk Smoldering Myeloma.

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outcome · POSTED

Percentage of Participants Without Disease Progression or Death at 12 Months

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outcome · POSTED

Safety and Tolerability of Curcumin in Combination With Piperine

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

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.
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Curcumin plus Piperine at a dose of 4 gram/5mg orally BID for 12 months
intervention Names
Drug: Curcumin plus Piperine
label
Prostate Cancer
type
EXPERIMENTAL
description
Curcumin plus Piperine at a dose of 4 gram/5mg orally BID for 12 months
intervention Names
Drug: Curcumin plus Piperine
label
Smoldering Multiple Myeloma (SMM)
type
EXPERIMENTAL
description
Curcumin plus Piperine at a dose of 4 gram/5mg orally BID for 12 months
intervention Names
Drug: Curcumin plus Piperine
label
Monoclonal Gammopathy of Unknown Significance (MGUS)
type
EXPERIMENTAL

interventions

arm Group Labels
Monoclonal Gammopathy of Unknown Significance (MGUS)
Prostate Cancer
Smoldering Multiple Myeloma (SMM)
description
Curcumin with piperine is a well-tolerated over-the-counter supplement.
name
Curcumin plus Piperine
other Names
Curcumin C3 Complex®
type
DRUG

Study design

allocation

NON_RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 30
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
To estimate the proportion of participants achieving a disease-specific response following curcumin and piperine supplementation administered at a dose of 2gm/10mg(2 tablets) orally twice daily for up to 12 months. For patients with early-stage prostate cancer, response was defined as ≥50% decrease in prostate-specific antigen (PSA) from baseline, confirmed at least 4 weeks apart. For patients with MGUS or low-risk SMM, response was defined per International Myeloma Working Group (IMWG) criteria as at least a partial response (≥50% reduction in serum M-protein). The overall response rate equals the number of participants achieving disease-specific response divided by total number analyzed.
measure
Response Rate of Curcumin & Piperine Supplementation in Patients on Active Surveillance for Either Early Stage Prostate Cancer or Patients on Observation for MGUS/Low-risk Smoldering Myeloma.
time Frame
From date of enrollment until the date of first documented response assessed up to 12 months

secondary Outcomes

description
Proportion of participants who remained free from disease progression or death from any cause at 12 months after enrollment. Participants without documented progression or death by 12 months were considered progression-free.
measure
Percentage of Participants Without Disease Progression or Death at 12 Months
time Frame
From enrollment to 12 months
description
Adverse events were summarized by grade and event type per CTCAE version 5.0. The safety population included all participants who received at least one dose of curcumin plus piperine. Results are presented as the number (percentage) of participants who experienced at least one adverse event.
measure
Safety and Tolerability of Curcumin in Combination With Piperine
time Frame
From start of study treatment through study completion, an average of 1 year for non-serious adverse events; and from screening through study completion, an average of 1 year for serious adverse events.

Full 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.
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.

Source references

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice