Curcumin to Improve Inflammation and Symptoms in Patients With Clonal Cytopenia of Undetermined Significance, Low Risk Myelodysplastic Syndrome, and Myeloproliferative Neoplasms

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of Southern California
Study ID
NCT06063486
Phase
PHASE2
Status
Recruiting
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Conditions

  • Clonal Cytopenia of Undetermined Significance
  • Essential Thrombocythemia
  • Myelodysplastic Syndrome
  • Myelofibrosis
  • Polycythemia Vera

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood samples
  • Bone Marrow Aspiration — PROCEDURE
    Undergo bone marrow aspiration
  • Bone Marrow Biopsy — PROCEDURE
    Undergo bone marrow biopsy
  • Curcumin/ Demethoxycurcumin/Bisdemethoxycurcumin-containing Supplement — DIETARY_SUPPLEMENT
    Given PO
  • Piperine Extract (Standardized) — DIETARY_SUPPLEMENT
    Given PO
  • Placebo Administration — DRUG
    Given PO
  • Questionnaire Administration — OTHER
    Ancillary studies

Study Details

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.

Key Dates

Start date
Mar 1, 2024
Status verified
Mar 2026
Primary completion
Dec 31, 2026
Completion
Mar 1, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I (C3 Complex/Bioperine)
    Patients receive C3 complex/Bioperine PO BID for 12 months in the absence of disease progression or unacceptable toxicity. Patients also undergo bone marrow aspiration and biopsy at baseline and follow up, and collection of blood samples throughout the trial.
  • Placebo Comparator: Arm II (placebo)
    Patients receive placebo PO BID for 12 months in the absence of disease progression or unacceptable toxicity. Patients also undergo bone marrow aspiration and biopsy at baseline and follow up, and collection of blood samples throughout the trial.

Primary Outcome Measure

Mean change in peripheral blood levels of inflammatory cytokines [ Time Frame: At baseline, 3 months, and 12 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Los Angeles General Medical CenterLos AngelesCalifornia90033
Christine Duran
[email protected]
323-865-0371
Casey L. O'Connell, MD (PRINCIPAL_INVESTIGATOR)
USC / Norris Comprehensive Cancer CenterLos AngelesCalifornia90033
Christine Duran
[email protected]
323-865-0371
Casey L. O'Connell, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Los Angeles General Medical Center· Los Angeles, CAUSC / Norris Comprehensive Cancer Center· Los Angeles, CA

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