Overview

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

Status:
Not yet recruiting
Trial end date:
2023-05-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Rochester
Treatments:
Curcumin
Piperine
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.