Curcumin for Clonal Cytopenia and Related Conditions
Curcumin to Improve Inflammation and Symptoms in Patients With Clonal Cytopenia of Undetermined Significance, Low Risk Myelodysplastic Syndrome, and Myeloproliferative Neoplasms
Recruiting
Phase 2Interventional Study
Clonal Cytopenia of Undetermined SignificanceEssential ThrombocythemiaMyelodysplastic SyndromeMyelofibrosisPolycythemia Vera
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
30 (estimated)
Sponsor
University of Southern California · Other
Who this trial is looking for
This trial is looking for adults with specific blood disorders like clonal cytopenia and low-risk myelodysplastic syndrome. Participants will take a curcumin supplement to see if it helps reduce inflammation and improve symptoms.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old.
I understand and am willing to sign consent forms.
I have been diagnosed with polycythemia vera, essential thrombocytosis, or myelofibrosis.
I have at least one measurable symptom that is severe.
I have a diagnosis of clonal cytopenia or low-risk myelodysplastic syndrome.
I have symptoms of fatigue with a specific score.
You may not be able to join if
I have taken curcumin supplements in the past.
I cannot understand or follow instructions.
I am receiving treatment for another cancer.
I have intermediate or high-risk myelodysplastic syndrome.
I am pregnant or nursing.
I am taking steroids or other anti-inflammatory medications.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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…
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.
Trial Locations
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Eligibility 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 diagnosti…
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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