UMLT20123 / Lipe / SMM & Prostate
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Lead Researcher: Brea Lipe
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.
More Details:
Eligibility:
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.