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NOT YET RECRUITING
NCT05433805
NA

Lifestyle-modifying Interventions in Low-risk MDS Patients

Sponsor: Technische Universität Dresden

View on ClinicalTrials.gov

Summary

Myelodysplastic syndromes (MDS) are acquired clonal stem cell diseases characterized by hematopoietic cell dysplasia, cytopenia, and the risk of progression to acute myeloid leukemia. In addition to clonal changes in the hematopoietic stem and progenitor cells itself, growing evidence suggests that inflammatory and metabolic changes in the bone marrow microenvironment play an important role in disease development and maintenance of the malignant clone. The positive impact of dietary interventions (e.g. fasting) and physical activity on inflammation and metabolic parameters could be shown in various benign inflammatory disease entities (e.g. atherosclerosis, chronic renal insufficiency, cystic fibrosis etc.). The aim of this study is to describe the hematological, metabolic, inflammatory, and microbiological changes after combined lifestyle-modifying interventions (outpatient physiotherapy and fasting mimicking diet (FMD) in patients with low-risk MDS.

Official title: Prospective Evaluation of Lifestyle-modifying Interventions on Disease Parameters, Inflammatory and Metabolic Processes in Low-risk MDS Patients

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2023-04

Completion Date

2026-10

Last Updated

2022-06-27

Healthy Volunteers

No

Interventions

OTHER

Fasting-mimicking diet (FMD) and physiotherapy

FMD is a diet held monthly during five days with the restriction of calories to less than 1000 kcal, glucose and proteins. Physiotherapy will be organized as home-based exercises explained by the physiotherapeutist at the beginning of the study.