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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
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.
Hematological improvement
Hemoglobin level at the EOT visit, g/dL
Time frame: 24 weeks
Evaluation of a priori metabolic parameters of MDS patients after combined physiotherapeutic and nutritive interventions
Panel measurement, mg/dL
Time frame: 6 months
Evaluation of a priori inflammatory parameters of MDS patients after combined physiotherapeutic and nutritive interventions
Panel measurement, ng/mL
Time frame: 6 months
Patients' adherence to therapy as an expression of the relevance of the lifestyle-modifying interventions in everyday life
Diary analysis
Time frame: 6 months
Impact on quality of life
QUALMS questionnaire
Time frame: 6 months
Impact on fatigue
Mean Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue score
Time frame: 6 months
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