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
Sponsors and collaborators
University of Southern California
Lead sponsor
National Cancer Institute (NCI)
Collaborator