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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prostate Cancer | Experimental | Curcumin plus Piperine at a dose of 4 gram/5mg orally BID for 12 months |
|
| Smoldering Multiple Myeloma (SMM) | Experimental | Curcumin plus Piperine at a dose of 4 gram/5mg orally BID for 12 months |
|
| Monoclonal Gammopathy of Unknown Significance (MGUS) | Experimental | Curcumin plus Piperine at a dose of 4 gram/5mg orally BID for 12 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Curcumin plus Piperine | Drug | Curcumin with piperine is a well-tolerated over-the-counter supplement. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | From date of enrollment until the date of first documented response assessed up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Without Disease Progression or Death at 12 Months | 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. | From enrollment to 12 months |
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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).
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:
At least one of the risk factors below that portends for an increased risk of progression to MM:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Brea Lipe | University of Rochester Wilmot Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester | Rochester | New York | 14623 | United States |
A total of 30 participants provided informed consent and considered enrolled. Due to withdrawal of consent by one enrolled participant prior to assignment to a treatment arm/group, there are only N=29 assigned to a treatment group after consent. This number (n=29)is reflected in the participant flow.
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| ID | Title | Description |
|---|---|---|
| FG000 | Prostate Cancer | Curcumin plus Piperine at a dose of 4 gram/5mg orally BID for 12 months Curcumin plus Piperine: Curcumin with piperine is a well-tolerated over-the-counter supplement. |
| FG001 | Smoldering Multiple Myeloma (SMM) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 7, 2023 |
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|
| Safety and Tolerability of Curcumin in Combination With Piperine |
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. |
| 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. |
Curcumin plus Piperine at a dose of 4 gram/5mg orally BID for 12 months
Curcumin plus Piperine: Curcumin with piperine is a well-tolerated over-the-counter supplement.
| FG002 | Monoclonal Gammopathy of Unknown Significance (MGUS) | Curcumin plus Piperine at a dose of 4 gram/5mg orally BID for 12 months Curcumin plus Piperine: Curcumin with piperine is a well-tolerated over-the-counter supplement. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Adults > or = to age 18 in years
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| ID | Title | Description |
|---|---|---|
| BG000 | Prostate Cancer | Curcumin plus Piperine at a dose of 4 gram/5mg orally BID for 12 months Curcumin plus Piperine: Curcumin with piperine is a well-tolerated over-the-counter supplement. |
| BG001 | Smoldering Multiple Myeloma (SMM) | Curcumin plus Piperine at a dose of 4 gram/5mg orally BID for 12 months Curcumin plus Piperine: Curcumin with piperine is a well-tolerated over-the-counter supplement. |
| BG002 | Monoclonal Gammopathy of Unknown Significance (MGUS) | Curcumin plus Piperine at a dose of 4 gram/5mg orally BID for 12 months Curcumin plus Piperine: Curcumin with piperine is a well-tolerated over-the-counter supplement. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Full Range | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | All enrolled participants | Posted | Count of Participants | Participants | From date of enrollment until the date of first documented response assessed up to 12 months |
|
|
| ||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Without Disease Progression or Death at 12 Months | 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. | All enrolled participants | Posted | Number | participants | From enrollment to 12 months |
| ||||||||||||||||||||||||||||||||||
| Secondary | Safety and Tolerability of Curcumin in Combination With Piperine | 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. | All enrolled participants | Posted | Number | participants | 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. |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Prostate Cancer | Curcumin plus Piperine at a dose of 2gm/10mg orally BID for 12 months Curcumin plus Piperine: Curcumin with piperine is a well-tolerated over-the-counter supplement. | 0 | 12 | 1 | 12 | 10 | 12 |
| EG001 | Smoldering Multiple Myeloma (SMM) | Curcumin plus Piperine at a dose of 2gm/10mg orally BID for 12 months Curcumin plus Piperine: Curcumin with piperine is a well-tolerated over-the-counter supplement. | 0 | 8 | 0 | 8 | 7 | 8 |
| EG002 | Monoclonal Gammopathy of Unknown Significance (MGUS) | Curcumin plus Piperine at a dose of 2gm/10mg orally BID for 12 months Curcumin plus Piperine: Curcumin with piperine is a well-tolerated over-the-counter supplement. | 0 | 9 | 0 | 9 | 8 | 9 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Esophageal perforation | Gastrointestinal disorders | CTCAE 5.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Alanine Aminotransferase increased | Investigations | CTCAE 5.0 | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | CTCAE 5.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTCAE 5.0 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | CTCAE 5.0 | Systematic Assessment |
| |
| constipation | Gastrointestinal disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Creatinine Increased | Investigations | CTCAE 5.0 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE 5.0 | Systematic Assessment |
| |
| dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Edema Limbs | General disorders | CTCAE 5.0 | Systematic Assessment | Right lower extremity edema |
|
| Endocrine Disorders-Other, specify | Endocrine disorders | CTCAE 5.0 | Systematic Assessment | Thyroid mass of unclear etiology, Goiter |
|
| Eye Disorders-Other, specify | Eye disorders | CTCAE 5.0 | Systematic Assessment | Diplopia |
|
| Fall | Injury, poisoning and procedural complications | CTCAE 5.0 | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Gastrointestinal Disorder -Other, Specify | Gastrointestinal disorders | CTCAE 5.0 | Systematic Assessment | Epigastric pain NOS |
|
| Gastrointestinal disorders-Other, specify | Gastrointestinal disorders | CTCAE 5.0 | Systematic Assessment | indigestion NOS |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Gastrointestinal disorders-Other,Specify | Gastrointestinal disorders | CTCAE 5.0 | Systematic Assessment | Heartburn |
|
| Urinary Frequency | Renal and urinary disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Infections and Infestations-Other,Specify | Infections and infestations | CTCAE 5.0 | Systematic Assessment | COVID-19 Infection |
|
| Thromboembolic Event | Vascular disorders | CTCAE 5.0 | Systematic Assessment | pulmonary embolism |
|
| Hematuria | Renal and urinary disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Hypercalcemia | Blood and lymphatic system disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Hyperkalemia | Blood and lymphatic system disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Injury,poisoning and procedural complication-Other,specify | Injury, poisoning and procedural complications | CTCAE 5.0 | Systematic Assessment | Laceration, lateral aspect, right back leg |
|
| Lung Infection | Respiratory, thoracic and mediastinal disorders | CTCAE 5.0 | Systematic Assessment | SARS-COVID-19 |
|
| Lymphocyte count decreased | Investigations | CTCAE 5.0 | Systematic Assessment |
| |
| Musculoskeletal and connective tissue disorder-Other,specify | Musculoskeletal and connective tissue disorders | CTCAE 5.0 | Systematic Assessment | Cricopharyngeal hypertrophy |
|
| Musculoskeletal and connective tissue disorder-Other,specify | Musculoskeletal and connective tissue disorders | CTCAE 5.0 | Systematic Assessment | Dupuyren's contracture |
|
| Musculoskeletal and connective tissue disorder-Other,specify | Musculoskeletal and connective tissue disorders | CTCAE 5.0 | Systematic Assessment | Radial Styloid Tenosynovitis |
|
| Nausea | Gastrointestinal disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Nervous system disorder-Other, specify | Nervous system disorders | CTCAE 5.0 | Systematic Assessment | numbness bilateral toes |
|
| Pain | General disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Respiratory, thoracic, and mediastinal disorder-Other, specify | Respiratory, thoracic and mediastinal disorders | CTCAE 5.0 | Systematic Assessment | Sinus discomfort |
|
| Sinus bradycardia | Cardiac disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Skin hypopigmentation | Skin and subcutaneous tissue disorders | CTCAE 5.0 | Systematic Assessment | White spots on arms and legs |
|
| Skin Infection | Skin and subcutaneous tissue disorders | CTCAE 5.0 | Non-systematic Assessment | Cellulitis, NOS |
|
| Tinnitus | Ear and labyrinth disorders | CTCAE 5.0 | Non-systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | CTCAE 5.0 | Systematic Assessment |
| |
| urinary retention | Renal and urinary disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Urinary Urgency | Renal and urinary disorders | CTCAE 5.0 | Systematic Assessment |
| |
| Sinus Tachycardia | Cardiac disorders | CTCAE 5.0 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brea Lipe | University of Rochester | (585) 273-1276 | Brea_Lipe@URMC.Rochester.edu |
| Oct 20, 2025 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 10, 2024 | Oct 22, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D009101 | Multiple Myeloma |
| D000075122 | Smoldering Multiple Myeloma |
| D008998 | Monoclonal Gammopathy of Undetermined Significance |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D011230 | Precancerous Conditions |
| D006942 | Hypergammaglobulinemia |
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| ID | Term |
|---|---|
| D003474 | Curcumin |
| C008922 | piperine |
| ID | Term |
|---|---|
| D036381 | Diarylheptanoids |
| D006536 | Heptanes |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Units | Counts |
|---|---|
| Participants |
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