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

NCT ID: NCT04731844

Last Updated: 2024-07-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-14
• Study Completion Date: 2025-05-31

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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Prostate Cancer

Curcumin plus Piperine at a dose of 4 gram/5mg orally BID for 12 months

Group Type: EXPERIMENTAL

Curcumin plus Piperine

Intervention Type: DRUG

Curcumin with piperine is a well-tolerated over-the-counter supplement.

Smoldering Multiple Myeloma (SMM)

Curcumin plus Piperine at a dose of 4 gram/5mg orally BID for 12 months

Group Type: EXPERIMENTAL

Curcumin plus Piperine

Intervention Type: DRUG

Curcumin with piperine is a well-tolerated over-the-counter supplement.

Monoclonal Gammopathy of Unknown Significance (MGUS)

Curcumin plus Piperine at a dose of 4 gram/5mg orally BID for 12 months

Group Type: EXPERIMENTAL

Curcumin plus Piperine

Intervention Type: DRUG

Curcumin with piperine is a well-tolerated over-the-counter supplement.

Interventions

Curcumin plus Piperine

Curcumin with piperine is a well-tolerated over-the-counter supplement.

Intervention Type: DRUG

Other Intervention Names

Curcumin C3 Complex®

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Brea Lipe

Professor - Department of Medicine , Hematology/Oncology (SMD)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brea Lipe

Role: PRINCIPAL_INVESTIGATOR

University of Rochester Wilmot Cancer Center

Locations

University of Rochester

Rochester, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Brea Lipe

Role: CONTACT

Brea_Lipe@URMC.Rochester.edu

(585) 273-1276

Facility Contacts

Brea Lipe

Role: primary

Brea_Lipe@URMC.Rochester.edu

585-273-1276

Other Identifiers

UMLT20123

Identifier Type: -

Identifier Source: org_study_id