Actively Recruiting
A Phase 2, Double-blind, Randomized Study to Compare the Effect of Curcumin Versus Placebo on Inflammatory Cytokines, Symptoms and Disease Parameters in Clonal Cytopenia of Undetermined Significance, Low-Risk Myelodysplastic Syndrome, and Myeloproliferative Neoplasms
Led by University of Southern California · Updated on 2026-03-27
30
Participants Needed
2
Research Sites
8 weeks
Total Duration
On this page
Sponsors
U
University of Southern California
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of a curcumin supplement (C3 complex/Bioperine) on inflammation and symptoms in patients with clonal cytopenia of undetermined significance (CCUS), low-risk myelodysplastic syndrome (LR-MDS), and myeloproliferative neoplasms (MPN). Chronic inflammation plays a role in the development of these diseases and contributes to patient symptoms. Curcumin is being studied for its anti-inflammatory and anti-cancer properties in these blood disorders. Participants are randomly assigned to one of two groups: one group receives the curcumin supplement orally twice daily for 12 months unless disease progression or unacceptable side effects occur, while the other group receives a placebo on the same schedule. Both groups undergo bone marrow aspiration and biopsy at the start and during follow-up, along with regular blood sample collection. During the study, participants undergo assessments of inflammatory cytokine levels and symptom scores at baseline, 3 months, and 12 months. Researchers also monitor changes in genetic mutations, DNA methylation patterns, and blood cell counts after 12 months. Safety is closely tracked through frequent visits during the first three months and every three months thereafter for a total of 12 months. After treatment, participants are followed annually for up to 10 years to monitor long-term effects and transfusion needs.
CONDITIONS
Brief Title
Curcumin to Improve Inflammation and Symptoms in Patients With Clonal Cytopenia of Undetermined Significance, Low Risk Myelodysplastic Syndrome, and Myeloproliferative Neoplasms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Ability to understand and willingness to sign a written informed consent
- Diagnosis of polycythemia vera, essential thrombocytosis, or myelofibrosis according to WHO 2016 criteria
- Presence of at least one symptom measurable by the MPN-Symptom Assessment Form with severity greater than 3 for MPN patients
- MPN patients must have stable disease and are unlikely to start new cytoreductive therapy; stable dose of hydroxyurea for at least 6 months allowed
- Diagnosis of clonal cytopenia of undetermined significance (CCUS) defined by persistent cytopenia for more than 6 months with specific blood count thresholds, normal cytogenetics, detectable MDS mutations, and non-diagnostic bone marrow morphology
- Diagnosis of low-risk myelodysplastic syndrome as defined by WHO 2016
- Minimum baseline fatigue symptom score of 25 on the symptom questionnaire
You will not qualify if you...
- Current intake of curcumin supplements including multivitamins and unwillingness to stop more than 24 hours before study start
- Inability to understand or follow study information
- Receiving active treatment for another cancer except hormonal therapy in remission or certain growth factors
- Having intermediate or high-risk myelodysplastic syndrome
- Pregnant or nursing individuals
- Use of oral or intravenous steroids or anti-inflammatory medications such as ibuprofen (over 200 mg/week), naproxen, aspirin (over 325 mg daily), or any herbal anti-inflammatory preparations
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months
Participants receive either curcumin-containing supplement or placebo orally twice daily for 12 months, unless disease progression or unacceptable side effects occur. Participants also undergo bone marrow aspiration and biopsy at the beginning and end of treatment, and blood samples are collected throughout.
Visits every 2 weeks for the first month, monthly for the next 2 months, then every 3 months during treatment
Duration - Up to 10 years
After completing treatment, participants are followed annually for up to 10 years to monitor long-term outcomes including transfusion requirements.
Annual visits
Trial Site Locations
Total: 2 locations
1
Los Angeles General Medical Center
Los Angeles, California, United States, 90033
Actively Recruiting
2
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Actively Recruiting
Research Team
C
Christine Duran
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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