Clinical trial NCT05433805: Lifestyle-modifying Interventions in Low-risk MDS Patients
Official title: Prospective Evaluation of Lifestyle-modifying Interventions on Disease Parameters, Inflammatory and Metabolic Processes in Low-risk MDS Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Myelodysplastic Syndromes
Keywords: Myelodysplastic syndrome
fasting-mimicking diet
physiotherapy
lifestyle modification
inflammation
metabolism
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
First posted: 2022-06-27
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Hematological improvement
timeFrame: 24 weeks
Secondary outcomes:
measure: Evaluation of a priori metabolic parameters of MDS patients after combined physiotherapeutic and nutritive interventions
timeFrame: 6 months
measure: Evaluation of a priori inflammatory parameters of MDS patients after combined physiotherapeutic and nutritive interventions
timeFrame: 6 months
measure: Patients' adherence to therapy as an expression of the relevance of the lifestyle-modifying interventions in everyday life
timeFrame: 6 months
measure: Impact on quality of life
timeFrame: 6 months
measure: Impact on fatigue
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References: