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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Curcumin with piperine is a well-tolerated over-the-counter supplement.
University of Rochester
Rochester, New York, United States
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.
Time frame: From date of enrollment until the date of first documented response assessed up to 12 months
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.
Time frame: From enrollment to 12 months
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.
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.
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