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

Launched by UNIVERSITY OF SOUTHERN CALIFORNIA · Sep 23, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring the effects of a curcumin supplement, which is derived from turmeric, on reducing inflammation and improving symptoms in patients with certain blood disorders, specifically clonal cytopenia of undetermined significance (CCUS), low-risk myelodysplastic syndrome (LR-MDS), and myeloproliferative neoplasms (MPN). Chronic inflammation can worsen these conditions and the symptoms associated with them. The study aims to see if curcumin can help manage these issues, as it has shown promise in fighting inflammation and has some anti-cancer properties.

To participate in this trial, individuals must be at least 18 years old and diagnosed with conditions like polycythemia vera, essential thrombocythemia, or myelofibrosis, as well as having persistent symptoms that can be measured. Importantly, participants should not currently be taking curcumin supplements or certain anti-inflammatories. Those who join the study can expect to receive the curcumin supplement and be monitored for any changes in their symptoms and inflammation levels. This trial is currently recruiting participants and aims to provide more insight into how curcumin may benefit patients with these blood disorders.

Gender

ALL

Eligibility criteria

• 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)