๐ฌIn plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
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)
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What it tests
- Biospecimen Collection
- Bone Marrow Aspiration
- Bone Marrow Biopsy
- Curcumin/ Demethoxycurcumin/Bisdemethoxycurcumin-containing Supplement
- Piperine Extract (Standardized)
Los Angeles General Medical Center
Los Angeles, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, United States
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.