RecruitingPhase 2NCT06063486

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

A Phase 2, Double-blind, Randomized Study to Compare the Effect of Curcumin Versus Placebo on Inflammatory Cytokines, Symptoms and Disease Parameters in Clonal Cytopenia of Undetermined Significance (CCUS), Low-Risk Myelodysplastic Syndrome (LR-MDS), and Myeloproliferative Neoplasms (MPNs)


Sponsor

University of Southern California

Enrollment

30 participants

Start Date

Mar 1, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria5

  • 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

Exclusion Criteria10

  • 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
  • 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)

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Interventions

PROCEDUREBiospecimen Collection

Undergo collection of blood samples

PROCEDUREBone Marrow Aspiration

Undergo bone marrow aspiration

PROCEDUREBone Marrow Biopsy

Undergo bone marrow biopsy

DIETARY_SUPPLEMENTCurcumin/ Demethoxycurcumin/Bisdemethoxycurcumin-containing Supplement

Given PO

DIETARY_SUPPLEMENTPiperine Extract (Standardized)

Given PO

DRUGPlacebo Administration

Given PO

OTHERQuestionnaire Administration

Ancillary studies


Locations(2)

Los Angeles General Medical Center

Los Angeles, California, United States

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States

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NCT06063486


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