Study on Curcumin and Piperine for Patients Monitoring Early Stage Prostate Cancer, Monoclonal Gammopathy, or Smoldering Myeloma
Sponsor: University of Rochester
ClinicalTrials ID:NCT04731844
This clinical trial is exploring whether taking curcumin and piperine supplements can help prevent or delay the progression of early stage prostate cancer, monoclonal gammopathy, or low-risk smoldering myeloma into more serious forms that require treatment.
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Program Overview
The aim of this study is to see if taking curcumin and piperine supplements can help slow down or prevent the progression of early stage prostate cancer, monoclonal gammopathy of undetermined significance (MGUS), or low-risk smoldering myeloma. Researchers will also look at a blood marker called MIC-1 to see if it can predict whether the condition is getting better or worse.
Description
This study is investigating whether a combination of curcumin and piperine supplements can help prevent or delay the progression of certain early stage cancers into more aggressive forms that need treatment. The focus is on prostate cancer, monoclonal gammopathy of undetermined significance (MGUS), and low-risk smoldering myeloma. Researchers will monitor a blood marker called MIC-1 to see if it can indicate changes in the disease. Participants will take 4 grams of curcumin and 5 mg of piperine twice a day. The study aims to provide insights into whether these supplements can be beneficial for patients under active surveillance or observation for these conditions.
Eligibility Criteria
Inclusion Criteria
- Must provide informed consent to participate.
- Age 18 years or older.
- Good overall health with a performance status of 70% or higher.
- Diagnosed with non-metastatic prostate cancer and choosing active surveillance, or diagnosed with MGUS or low-risk smoldering myeloma and currently under observation.
- For MGUS or low-risk smoldering myeloma, diagnosis must meet specific criteria:
- MGUS: Low levels of M-protein in blood, less than 10% abnormal plasma cells in bone marrow, and no organ damage.
- Smoldering Myeloma: Higher levels of M-protein or more abnormal plasma cells, but still no organ damage.
- Must have at least one risk factor for progression to multiple myeloma, such as abnormal blood test results or a high percentage of abnormal plasma cells in bone marrow.
Exclusion Criteria
- Currently taking curcumin or piperine supplements.
- Planning to start new supplements during the study.
- Prostate cancer patients planning to undergo curative treatment like surgery or radiation.
- MGUS or smoldering myeloma patients showing signs of disease progression needing treatment.
- Have other conditions like plasma cell leukemia, amyloidosis, or POEMS syndrome.
- Pregnant, breastfeeding, or planning to become pregnant during the study.
- Recent major surgery or significant injury within four weeks before joining the study.
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