Curcumin for Inflammation and Symptoms in Blood Disorders
This study is testing whether a curcumin supplement (containing curcumin, demethoxycurcumin, bisdemethoxycurcumin, and piperine extract) can help reduce inflammation and improve symptoms in people with certain blood disorders. These conditions include clonal cytopenia of undetermined significance (CCUS), low-risk myelodysplastic syndrome (LR-MDS), and myeloproliferative neoplasms (MPN) like polycythemia vera (PV), essential thrombocythemia (ET), or myelofibrosis (MF). Researchers want to see how the supplement changes levels of inflammatory cytokines (proteins involved in inflammation) and your symptom scores over 12 months. You may be able to join if you are 18 or older, have one of these diagnoses, and meet other health criteria. The study is currently recruiting 30 participants.
- Study design
- This is an interventional study with 30 planned participants. Patients will be randomly assigned to receive either the curcumin supplement or a placebo.
- What's involved
- You would take the curcumin supplement or placebo by mouth twice daily for 12 months. You would also have blood samples collected and may undergo bone marrow aspiration and biopsy.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your inflammatory cytokine levels and symptom scores will be measured at baseline, 3 months, and 12 months.
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Curcumin to Improve Inflammation and Symptoms in Patients With Clonal Cytopenia of Undetermined Significance, Low Risk Myelodysplastic Syndrome, and Myeloproliferative Neoplasms
At a glance
Conditions
Where it's being run
2 sites across 1 statesStudy leadership
- Casey L O'Connell, MD · PRINCIPAL_INVESTIGATOR · University of Southern California
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Mean change in peripheral blood levels of inflammatory cytokinesAt baseline, 3 months, and 12 months
Interleukin (IL) 1beta, IL-6, IL-18, transforming growth factor-beta, and tumor necrosis factor-alpha will be assessed. Mean inflammatory cytokine changes in the treatment group will be compared to that of the control group. A two-sided two-sample unequal-variance t-test will be applied to compare the difference of the mean of changes at 12-months from the baseline measurement between the two arms, respectively. P-values from the test and the 95% confidence interval of the estimated difference will be reported for each of the inflammatory cytokines.
- Mean change in symptom scores for clonal cytopenia of undetermined significance and low risk myelodysplastic syndrome patientsAt baseline, 3 months, 12 months
Symptoms scores will be assessed using the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 version 3 (EORTC-QLQ-C30 version 3).This is a validated tool for assessing health-related quality of life in cancer patients. The questionnaire is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. Scores range from 0 to 100. A high scale score represents a higher response level. A high score for a functional scale represents a high/healthy level of functioning. A high score for the global health status/ QoL represents a high QoL and a high score for a symptom scale/item represents a high level of symptomatology/problems.(no symptom) to 10 (worst possible symptom).
- Mean change in symptom scores for myeloproliferative neoplasm (MPN) patientsAt baseline, 3 months, 12 months
MPN-related symptoms will be assessed using the Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score. Possible scores range from 0 (no symptom) to 10 (worst possible symptom).