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New treatment option for Clonal Cytopenia of Undetermined Significance
Official title Curcumin to Improve Inflammation and Symptoms in Patients With Clonal Cytopenia of Undetermined Significance, Low Risk Myelodysplastic Syndrome, and Myeloproliferative Neoplasms
ClinicalTrials.gov ID: NCT06063486
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 10 years
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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...
- 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
See the full eligibility 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 10 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.