ClinicalTrials.Veeva

Menu

Lifestyle-modifying Interventions in Low-risk MDS Patients (MDS-LIME)

T

Technische Universität Dresden

Status

Not yet enrolling

Conditions

Myelodysplastic Syndromes

Treatments

Other: Fasting-mimicking diet (FMD) and physiotherapy

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

36 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

36 participants in 2 patient groups

FMD first
Experimental group
Description:
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.
Treatment:
Other: Fasting-mimicking diet (FMD) and physiotherapy
Physiotherapy first
Experimental group
Description:
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.
Treatment:
Other: Fasting-mimicking diet (FMD) and physiotherapy

Trial contacts and locations

0

Loading...

Central trial contact

Ekaterina Balaian, Dr.; Katja Sockel, Dr.

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems