Using curcumin and piperine to prevent cancer progression in patients under observation
Efficacy of Curcumin and Piperine in Patients on Active Surveillance for Either Monoclonal Gammopathy of Unknown Significance (MGUS), Low-risk Smoldering Multiple Myeloma (SMM) or Early Stage Prostate Cancer: A Pilot Study
This study is testing if taking curcumin and piperine every day can help people with early-stage prostate cancer or certain blood disorders avoid worsening their condition.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Rochester Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Rochester, New York) |
| Trial ID | NCT04731844 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of curcumin and piperine supplementation on patients with early-stage prostate cancer, monoclonal gammopathy of undetermined significance (MGUS), or low-risk smoldering myeloma (SMM) who are under active surveillance. Participants will receive a daily dose of 4 grams of curcumin and 5 mg of piperine to assess whether this combination can delay or prevent the progression of their conditions. The study will also evaluate the blood marker MIC-1 to determine its effectiveness in predicting disease outcomes.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with early-stage prostate cancer on active surveillance or those diagnosed with MGUS or low-risk SMM currently under observation.
Not a fit: Patients with advanced cancer or those requiring immediate treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a non-invasive method to delay cancer progression and improve patient outcomes.
How similar studies have performed: While the use of curcumin and piperine in cancer treatment is being explored, this specific approach in the context of these conditions is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Rochester, New York
- University of Rochester — Rochester, New York, United States (Recruiting)
Study contacts
- Principal investigator: Brea Lipe — University of Rochester Wilmot Cancer Center
- Study coordinator: Brea Lipe
- Email: Brea_Lipe@URMC.Rochester.edu
- Phone: (585) 273-1276
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.