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

Overview

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

• 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.

Primary outcome measures

• Hematological improvement [Time frame: 24 weeks]

Secondary outcome measures (5)

• Evaluation of a priori metabolic parameters of MDS patients after combined physiotherapeutic and nutritive interventions [Time frame: 6 months]
• Evaluation of a priori inflammatory parameters of MDS patients after combined physiotherapeutic and nutritive interventions [Time frame: 6 months]
• Patients' adherence to therapy as an expression of the relevance of the lifestyle-modifying interventions in everyday life [Time frame: 6 months]
• Impact on quality of life [Time frame: 6 months]
• Impact on fatigue [Time frame: 6 months]

Eligibility criteria

Inclusion criteria

• 18-75 years of age
• Cytomorphologically confirmed MDS or MDS/MPN according to WHO criteria (incl. MDS-RARS-T, CMML)
• IPSS-R very low, low, or intermediate
• Hemoglobin <11 g/dL (6.8 mmol/l)
• Non-transfusion dependent (NTD) per IWG 2018 criteria (≤2 blood transfusions within 16 weeks prior to inclusion in the study)
• ECOG≤2
• Body mass index (BMI) ≥ 20 kg/m2
• Written informed consent of the subject after clarification

Exclusion criteria

• AML
• MDS IPSS-R high or very high
• History of HSCT
• MDS-specific drug therapy (including erythropoietin, erythropoiesis-modulating agents, lenalidomide, iron chelation, hypomethylating agents) ongoing or planned in the next 6 months
• Diabetes mellitus requiring therapy or any other known metabolic disease
• Application of systemic cortisone-containing drugs
• Known psychiatric eating disorder (e.g. anorexia nervosa, bulimia)
• Physical inability to follow the physical and/or nutritive interventions
• simultaneous participation in another interventional clinical trial (including within the last 4 weeks before inclusion)
• 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
• pregnant or breastfeeding women
• indications that the subject is unlikely to adhere to the protocol (e.g., lack of compliance)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT05433805 · 2020

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗