A Dietary Study for People With Clonal Hematopoiesis
ConditionClonal Hematopoiesis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center
About this trial
The researchers are doing this study to find out whether a high-fiber plant-based diet (HFPBD) can improve quality of life for people with CH. A HFPBD includes foods that are mainly from plants (for example, fruits,vegetables, nuts, beans, and whole grains). The researchers will measure quality of life by having participants complete questionnaires/surveys.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients must have confirmed clonal hematopoiesis via next generation sequencing (NGS) of blood or bone marrow biopsy sample
Patients with clonal cytopenias of undetermined significance (CCUS) are eligible if a bone marrow biopsy is done to exclude other causes.
Variant allele frequency must be ≥2% for mutation as measured by (NGS)
Treatment at MSK or at sites listed below that uses EPIC for electronic medical records and willing to share records with MSK through EPIC's care everywhere or through MSK's shared care network. If not meeting this criterion, decision to allow for participation is per PI discretion.
Disqualifiers
Prior MDS/AML directed therapy
Chemotherapy, radiation, or immunotherapy within the past year (surgical- resection only or other cancer/precancer on observation is eligible)
Patients with a concurrent malignancy whose natural history or treatment may compromise completion of this trial are excluded.
Concurrent pregnancy will make a participant ineligible to participate
Trial design
Design model
Parallel
Treatments tested in this trial
high-fiber plant-based meals
Other interventionA meal service will ship 12 frozen prepared meals per week to your home.
fermented foods
Other interventionFermented foods will be encouraged on the diet. Fermented foods contain probiotics that help support a balanced gut microbiome and might improve overall digestion.
supplements
Dietary supplementPatients will be recommended by research dietitian to take a weekly vitamin B12 supplement (at least 500 mcg weekly)
surveys
Other interventionQOL will be measured with the EORTC QLQ C30
Treatment groups
36 Participants
are divided into 2 treatment groupsGroup A: High Fiber Plant-Based DietExperimental treatment 4 interventions
Group B: Usual care armActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
compare the rates of improvement in Quality Of Life
using the Quality of Life Global Health Status at W13D1 Scoring will be based on standard EORTC criteria
Time frame
up to 12 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov