Myelodysplastic Syndromes
Conditions
Keywords
Myelodysplastic syndrome, fasting-mimicking diet, physiotherapy, lifestyle modification, inflammation, metabolism
Brief 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.
Interventions
OTHERFasting-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.
Sponsors
Technische Universität Dresden
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 18-75 years of age 2. Cytomorphologically confirmed MDS or MDS/MPN according to WHO criteria (incl. MDS-RARS-T, CMML) 3. IPSS-R very low, low, or intermediate 4. Hemoglobin \<11 g/dL (6.8 mmol/l) 5. Non-transfusion dependent (NTD) per IWG 2018 criteria (≤2 blood transfusions within 16 weeks prior to inclusion in the study) 6. ECOG≤2 7. Body mass index (BMI) ≥ 20 kg/m2 8. Written informed consent of the subject after clarification
Exclusion criteria
1. AML 2. MDS IPSS-R high or very high 3. History of HSCT 4. MDS-specific drug therapy (including erythropoietin, erythropoiesis-modulating agents, lenalidomide, iron chelation, hypomethylating agents) ongoing or planned in the next 6 months 5. Diabetes mellitus requiring therapy or any other known metabolic disease 6. Application of systemic cortisone-containing drugs 7. Known psychiatric eating disorder (e.g. anorexia nervosa, bulimia) 8. Physical inability to follow the physical and/or nutritive interventions 9. simultaneous participation in another interventional clinical trial (including within the last 4 weeks before inclusion) 10. addictions or other illnesses that do not allow the person concerned to assess the nature and extent of the clinical trial and its possible consequences 11. pregnant or breastfeeding women 12. indications that the subject is unlikely to adhere to the protocol (e.g., lack of compliance)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hematological improvement | 24 weeks | Hemoglobin level at the EOT visit, g/dL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of a priori metabolic parameters of MDS patients after combined physiotherapeutic and nutritive interventions | 6 months | Panel measurement, mg/dL |
| Evaluation of a priori inflammatory parameters of MDS patients after combined physiotherapeutic and nutritive interventions | 6 months | Panel measurement, ng/mL |
| Patients' adherence to therapy as an expression of the relevance of the lifestyle-modifying interventions in everyday life | 6 months | Diary analysis |
| Impact on quality of life | 6 months | QUALMS questionnaire |
| Impact on fatigue | 6 months | Mean Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue score |
Contacts
Primary ContactEkaterina Balaian, Dr.
Backup ContactKatja Sockel, Dr.
Outcome results
None listed