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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FMD first | Experimental | Patients receive nutritional counselling on the principles of the FMD diet and individual recommendations for optimising the micronutrient balance (vitamins, trace elements) based on their corresponding baseline values. A food diary is given to the patients to assess treatment adherence on FMD days. This is followed by a combined nutritive and physiotherapeutic interventions from week 13 for a further 3 months. Patients will be instructed about ambulatory exercises during a physiotherapeutic counselling, scheduled in week 13. Physiotherapy exercises should only be carried out on FMD-free days. Patients also receive a diary in which they document daily physical activity. |
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| Physiotherapy first | Experimental | Patients receive physiotherapy counselling, with structured ambulatory exercises shown and explained. The patients receive a diary where they have to document their physical activity every day. This is followed by a combined nutritive and physiotherapeutic interventions from week 13 for a further 3 months. For this purposphe, nutritional counselling on the principles of the FMD diet is planned for week 13. In addition, individual recommendations for optimising the micronutrient balance (vitamins, trace elements) are given based on the respective baseline values. The physiotherapeutic exercises are to be carried out only on FMD-free days. Patients will also be given a food diary to assess treatment adherence on FMD days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fasting-mimicking diet (FMD) and physiotherapy | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Hematological improvement | Hemoglobin level at the EOT visit, g/dL | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of a priori metabolic parameters of MDS patients after combined physiotherapeutic and nutritive interventions | Panel measurement, mg/dL | 6 months |
| Evaluation of a priori inflammatory parameters of MDS patients after combined physiotherapeutic and nutritive interventions |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ekaterina Balaian, Dr. | Contact | +4935145819493 | Ekaterina.Balaian@ukdd.de | |
| Katja Sockel, Dr. | Contact | +4935145815627 | katja.sockel@ukdd.de |
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| ID | Term |
|---|---|
| D009190 | Myelodysplastic Syndromes |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D010335 | Pathologic Processes |
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|
Panel measurement, ng/mL |
| 6 months |
| Patients' adherence to therapy as an expression of the relevance of the lifestyle-modifying interventions in everyday life | Diary analysis | 6 months |
| Impact on quality of life | QUALMS questionnaire | 6 months |
| Impact on fatigue | Mean Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue score | 6 months |
| D013568 | Pathological Conditions, Signs and Symptoms |