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Curcumin to Improve Inflammation and Symptoms in Patients With Clonal Cytopenia of Undetermined Significance, Low Risk Myelodysplastic Syndrome, and Myeloproliferative Neoplasms

RECRUITINGPhase 2Sponsored by University of Southern California
Actively Recruiting
PhasePhase 2
SponsorUniversity of Southern California
Started2024-03-01
Est. completion2026-03-01
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations2 sites

Summary

This phase II trial evaluates how a curcumin supplement (C3 complex/Bioperine) changes the inflammatory response and symptomatology in patients with clonal cytopenia of undetermined significance (CCUS), low risk myelodysplastic syndrome (LR-MDS), and myeloproliferative neoplasms (MPN). Chronic inflammation drives disease development and contributes to symptoms experienced by patients with CCUS, LR-MDS, and MPN. Curcumin has been shown to have anti-inflammatory and anti-cancer properties and has been studied in various chronic illnesses and hematologic diseases.

Eligibility

Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria:

* Age \>= 18
* Eastern Cooperative Oncology Group (ECOG) =\< 2
* Ability to understand and willingness to sign a written informed consent
* Diagnosis of polycythemia vera (PV), essential thrombocytosis (ET) or myelofibrosis (MF) per World Health Organization (WHO) 2016 diagnostic criteria

  * Presence of at least one symptom measurable using the MPN-/Symptom Assessment Form (SAF) with a severity greater than 3
  * MPN patients determined to have stable disease undergoing surveillance and unlikely to require initiation of new cytoreductive therapy (i.e., hydroxyurea, ruxotinib, interferon within the study period); patients on a stable dose of hydroxyurea for at least 6 months who meet the other inclusion/exclusion criteria may be included
* A diagnosis of CCUS or LR-MDS

  * CCUS defined as persistent cytopenia for \> 6 months (hemoglobin \[Hgb\] \< 11.3 g/dL \[7 mmol/L\] in women and Hgb \< 12.9 g/dL \[8 mmol/L\] in men, platelet \< 150 x 10\^9/L or neutrophils \< 1.8 x 10\^9/L), normal cytogenetics, presence of detectable MDS associated mutations and bone marrow morphology non-diagnostic of MDS or any other malignancies
  * LR-MDS as defined by WHO 2016 diagnosis criteria
  * Minimum baseline symptom score of 25 in the fatigue section of the symptom questionnaire

Exclusion Criteria:

* Patients with intake of curcumin as a dietary supplement, including multivitamin and unwillingness to quit more than 24 hours before study start
* Patients with inability to understand and adhere to information given
* Patients receiving active treatment for another malignancy except with hormonal therapy for a malignancy considered to be in remission or growth factors (erythropoietin, granulocyte colony-stimulating factor \[G-CSF\] and luspatercept)
* Patients with intermediate or high-risk MDS
* Patients must not be pregnant or nursing
* Patients must not be on any oral or intravenous steroid or any other anti-inflammatories (ibuprofen \> 200mg/week or 400mg/month, naproxen of any dose, \> 325mg aspirin daily, any herbal anti-inflammatory concoction of any dose)

Conditions6

CancerClonal Cytopenia of Undetermined SignificanceEssential ThrombocythemiaMyelodysplastic SyndromeMyelofibrosisPolycythemia Vera

Locations2 sites

Los Angeles General Medical Center
Los Angeles, California, 90033
Christine Duran323-865-0371duran_c@med.usc.edu
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Christine Duran323-865-0371duran_c@med.usc.edu

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