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Curcumin Supplement for Myelodysplastic Syndrome and Myeloproliferative Disorders

Phase 2

Recruiting

Led By Casey L O'Connell, MD

Research Sponsored by University of Southern California

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

LR-MDS as defined by WHO 2016 diagnosis criteria

A diagnosis of CCUS or LR-MDS

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 10 years

Awards & highlights

Study Summary

This trial looks at how a curcumin supplement can reduce inflammation and symptoms in patients with CCUS, LR-MDS, and MPN. Curcumin has anti-inflammatory and anti-cancer properties and has been studied for various diseases.

Who is the study for?

Adults over 18 with certain blood disorders like polycythemia, thrombocytosis, or myelofibrosis who are stable and not likely to need new treatments soon. Also for those with clonal cytopenia or low-risk myelodysplastic syndrome, experiencing symptoms like fatigue. Not for pregnant/nursing individuals, those on steroids/anti-inflammatories, or taking curcumin supplements.Check my eligibility

What is being tested?

This phase II trial tests if a curcumin supplement (with anti-inflammatory properties) can reduce inflammation and improve symptoms in patients with specific pre-leukemia conditions and other related blood disorders.See study design

What are the potential side effects?

While the trial description does not specify side effects of curcumin, generally it may cause digestive upset, headache, rash or yellow stool; high doses could lead to more serious issues such as ulcers or liver problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My condition is low-risk myelodysplastic syndrome.

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I have been diagnosed with CCUS or low-risk MDS.

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I have low blood counts for over 6 months, no genetic abnormalities, and specific mutations but no clear cancer diagnosis from bone marrow tests.

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I have been diagnosed with PV, ET, or MF according to WHO criteria.

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I have a symptom from my condition that is quite bothersome.

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My fatigue level is high, scoring at least 25 on a symptom questionnaire.

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I am 18 years old or older.

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I can perform daily activities with minimal assistance.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Mean change in peripheral blood levels of inflammatory cytokines

Mean change in symptom scores for clonal cytopenia of undetermined significance and low risk myelodysplastic syndrome patients

Mean change in symptom scores for myeloproliferative neoplasm (MPN) patients

Secondary outcome measures

Change in peripheral blood cell counts

Change in the deoxyribonucleic acid methylation pattern

Change in the rate of transfusion requirement measured

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm I (C3 Complex/Bioperine)Experimental Treatment6 Interventions

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.

Group II: Arm II (placebo)Placebo Group5 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 2

~1700

Bone Marrow Aspiration

2011

Completed Phase 2

~1740

Bone Marrow Biopsy

2021

Completed Phase 2

~10

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,670 Previous Clinical Trials

40,926,706 Total Patients Enrolled

University of Southern CaliforniaLead Sponsor

906 Previous Clinical Trials

1,596,258 Total Patients Enrolled

Casey L O'Connell, MDPrincipal InvestigatorUniversity of Southern California

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA sanctioned Arm I (C3 Complex/Bioperine)?

"Based on our assessment, Arm I (C3 Complex/Bioperine) was scored a 2 due to the fact that there is evidence of safety but not efficacy from this Phase 2 trial."

Answered by AI

Are there vacancies for participants with this research endeavor?

"Based on the data hosted on clinicaltrials.gov, no further participants are required for this study at present. The trial was posted to the website in October 2nd 2023 and last updated September 23rd 2023. Although recruitment is not open now, there are presently 4230 other studies recruiting patients across various locations."

Answered by AI

What impact is the research study expected to have?

"The principal objective of this clinical trial, which will be assessed at the onset and after 3 months and 12 months, is to measure changes in peripheral blood levels of inflammatory cytokines. Secondary goals include alterations of deoxyribonucleic acid methylation pattern evaluated using parametric two-sample t-tests and nonparametric Wilcoxon rank sum tests (under no assumption regarding sample distribution), comparison between pre-treatment and post-treatment peripheral cell counts employing parametric methods such as two-sample t-tests or nonparametricWilcoxon rank sum tests, ultimately determining the safety profile of curcumin for patients with CCUS"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Curcumin to Improve Inflammation and Symptoms in Patients With Clonal Cytopenia of Undetermined Significance, Low Risk Myelodysplastic Syndrome, and Myeloproliferative Neoplasms". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06063486.

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