Curcumin for treating inflammation and symptoms in blood disorders
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)
This study is testing if a curcumin supplement can help reduce inflammation and improve symptoms in people with certain blood disorders.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Southern California Academic / other |
| Drugs / interventions | ruxotinib |
| Locations | 2 sites (Los Angeles, California and 1 other locations) |
| Trial ID | NCT06063486 on ClinicalTrials.gov |
What this trial studies
This phase II trial evaluates the effects of a curcumin supplement on inflammation and symptoms in patients with clonal cytopenia of undetermined significance, low risk myelodysplastic syndrome, and myeloproliferative neoplasms. Patients are randomized to receive either curcumin or a placebo for 12 months, with assessments of inflammatory cytokine levels, symptom severity, and safety. The study also explores the impact of curcumin on genetic mutations and blood cell characteristics. Bone marrow biopsies and blood samples will be collected to monitor changes throughout the trial.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with specific blood disorders who have measurable symptoms and stable disease.
Not a fit: Patients requiring immediate disease-modifying therapy or those with severe disease progression may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new, non-invasive treatment option to alleviate symptoms and reduce inflammation in patients with specific blood disorders.
How similar studies have performed: While curcumin has shown promise in various chronic illnesses, this specific application in blood disorders is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Los Angeles, California and 1 other locations
- Los Angeles General Medical Center — Los Angeles, California, United States (Recruiting)
- USC / Norris Comprehensive Cancer Center — Los Angeles, California, United States (Recruiting)
Study contacts
- Principal investigator: Casey L O'Connell, MD — University of Southern California
- Study coordinator: Christine Duran
- Email: duran_c@med.usc.edu
- Phone: 323-865-0371
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.