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)

Description

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.PRIMARY OBJECTIVES: I. To compare the change in inflammatory cytokine levels in study patients treated with curcumin versus placebo over a 12-month follow-up period. II. To compare the change in symptomatology in study patients treated with curcumin versus placebo over a 12-month follow-up period. SECONDARY OBJECTIVES: I. To investigate the effect on variant allele frequency (VAF) of baseline mutations in study patients treat

Trial Eligibility

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)

Study Info

Interventions

Locations Recruiting

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