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NCT Number: NCT05433805

Lifestyle-modifying Interventions in Low-risk MDS Patients

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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Key information

Conditions

Myelodysplastic Syndromes Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Hematological improvement

    Time frame: 24 weeks

    Hemoglobin level at the EOT visit, g/dL

Secondary outcomes

  1. Evaluation of a priori metabolic parameters of MDS patients after combined physiotherapeutic and nutritive interventions

    Time frame: 6 months

    Panel measurement, mg/dL

  2. Evaluation of a priori inflammatory parameters of MDS patients after combined physiotherapeutic and nutritive interventions

    Time frame: 6 months

    Panel measurement, ng/mL

  3. Patients' adherence to therapy as an expression of the relevance of the lifestyle-modifying interventions in everyday life

    Time frame: 6 months

    Diary analysis

  4. Impact on quality of life

    Time frame: 6 months

    QUALMS questionnaire

  5. Impact on fatigue

    Time frame: 6 months

    Mean Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue score

Study contacts

Contact information is provided by the study sponsor or research team.

Ekaterina Balaian, Dr.

CONTACT

[email protected]

+4935145819493

Katja Sockel, Dr.

CONTACT

[email protected]

+4935145815627

Sponsors and collaborators

Lead sponsor

Technische Universität Dresden

Other

Registry information

Official study title

Prospective Evaluation of Lifestyle-modifying Interventions on Disease Parameters, Inflammatory and Metabolic Processes in Low-risk MDS Patients

Acronym: MDS-LIME

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jun 27, 2022
Registry last updated
Jun 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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