Curcumin for treating inflammation and symptoms in blood disorders

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.