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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Southern California

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Biospecimen Collection
  • Bone Marrow Aspiration
  • Bone Marrow Biopsy
  • Curcumin/ Demethoxycurcumin/Bisdemethoxycurcumin-containing Supplement
  • Piperine Extract (Standardized)
  • Placebo Administration
  • Questionnaire Administration

Treatment groups

30 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Southern California

Lead sponsor

National Cancer Institute (NCI)

Collaborator