Trial Title:
Curcumin to Improve Inflammation and Symptoms in Patients With Clonal Cytopenia of Undetermined Significance, Low Risk Myelodysplastic Syndrome, and Myeloproliferative Neoplasms
NCT ID:
NCT06063486
Condition:
Clonal Cytopenia of Undetermined Significance
Essential Thrombocythemia
Myelodysplastic Syndrome
Myelofibrosis
Polycythemia Vera
Conditions: Official terms:
Neoplasms
Preleukemia
Polycythemia Vera
Myelodysplastic Syndromes
Myeloproliferative Disorders
Polycythemia
Thrombocytosis
Thrombocythemia, Essential
Cytopenia
Syndrome
Curcumin
Piperine
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Participant, Investigator)
Intervention:
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo collection of blood samples
Arm group label:
Arm I (C3 Complex/Bioperine)
Arm group label:
Arm II (placebo)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Procedure
Intervention name:
Bone Marrow Aspiration
Description:
Undergo bone marrow aspiration
Arm group label:
Arm I (C3 Complex/Bioperine)
Arm group label:
Arm II (placebo)
Intervention type:
Procedure
Intervention name:
Bone Marrow Biopsy
Description:
Undergo bone marrow biopsy
Arm group label:
Arm I (C3 Complex/Bioperine)
Arm group label:
Arm II (placebo)
Other name:
Biopsy of Bone Marrow
Other name:
Biopsy, Bone Marrow
Intervention type:
Dietary Supplement
Intervention name:
Curcumin/ Demethoxycurcumin/Bisdemethoxycurcumin-containing Supplement
Description:
Given PO
Arm group label:
Arm I (C3 Complex/Bioperine)
Other name:
Curcumin C3 Complex
Intervention type:
Dietary Supplement
Intervention name:
Piperine Extract (Standardized)
Description:
Given PO
Arm group label:
Arm I (C3 Complex/Bioperine)
Other name:
Bioperine
Other name:
Standardized Piperine Extract
Intervention type:
Drug
Intervention name:
Placebo Administration
Description:
Given PO
Arm group label:
Arm II (placebo)
Other name:
Sugar pills
Intervention type:
Other
Intervention name:
Questionnaire Administration
Description:
Ancillary studies
Arm group label:
Arm I (C3 Complex/Bioperine)
Arm group label:
Arm II (placebo)
Summary:
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.
Detailed description:
PRIMARY OBJECTIVES:
I. To compare the change in inflammatory cytokine levels in study patients treated with
curcumin versus placebo over a 12-month follow-up period.
II. To compare the change in symptomatology in study patients treated with curcumin
versus placebo over a 12-month follow-up period.
SECONDARY OBJECTIVES:
I. To investigate the effect on variant allele frequency (VAF) of baseline mutations in
study patients treated with curcumin versus placebo.
II. To investigate the effect on methylation patterns in study patients treated with
curcumin versus placebo.
III. To evaluate the effect on peripheral blood cells in study patients treated with
curcumin versus placebo.
IV. To assess the safety of curcumin for patients with CCUS/LR-MDS and symptomatic MPN
who do not require disease-modifying therapy.
EXPLORATORY OBJECTIVE:
I. To investigate the correlation between inflammatory cytokine levels and symptom scores
in study patients treated with curcumin versus placebo.
OUTLINE: Patients are randomized to 1 of 2 arms.
Arm I: Patients receive curcumin/demethoxycurcumin/bisdemethoxycurcumin-containing
supplement (C3 complex)/piperine extract (standardized) (Bioperine) orally (PO) twice
daily (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.
Arm II: 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.
After completion of study treatment, patients are followed up annually for up to 10
years.
Criteria for 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 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)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Los Angeles General Medical Center
Address:
City:
Los Angeles
Zip:
90033
Country:
United States
Status:
Recruiting
Contact:
Last name:
Christine Duran
Phone:
323-865-0371
Email:
duran_c@med.usc.edu
Investigator:
Last name:
Casey L. O'Connell, MD
Email:
Principal Investigator
Facility:
Name:
USC / Norris Comprehensive Cancer Center
Address:
City:
Los Angeles
Zip:
90033
Country:
United States
Status:
Recruiting
Contact:
Last name:
Christine Duran
Phone:
323-865-0371
Email:
duran_c@med.usc.edu
Investigator:
Last name:
Casey L. O'Connell, MD
Email:
Principal Investigator
Start date:
March 1, 2024
Completion date:
March 1, 2027
Lead sponsor:
Agency:
University of Southern California
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
University of Southern California
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06063486
