Lifestyle-modifying Interventions in Low-risk MDS Patients

Myelodysplastic Syndromes Clinical Trial

— MDS-LIME  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05433805
• Other study ID #: 2020
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2023
• Est. completion date: October 2026

Study information

• Verified date: June 2022
• Source: Technische Universität Dresden
• Contact: Ekaterina Balaian, Dr.
• Phone: +4935145819493
• Email: Ekaterina.Balaian[@]ukdd.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 36
• Est. completion date: October 2026
• Est. primary completion date: April 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Myelodysplastic Syndromes
• Preleukemia

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität Dresden

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hematological improvement	Hemoglobin level at the EOT visit, g/dL	24 weeks
Secondary	Evaluation of a priori metabolic parameters of MDS patients after combined physiotherapeutic and nutritive interventions	Panel measurement, mg/dL	6 months
Secondary	Evaluation of a priori inflammatory parameters of MDS patients after combined physiotherapeutic and nutritive interventions	Panel measurement, ng/mL	6 months
Secondary	Patients' adherence to therapy as an expression of the relevance of the lifestyle-modifying interventions in everyday life	Diary analysis	6 months
Secondary	Impact on quality of life	QUALMS questionnaire	6 months
Secondary	Impact on fatigue	Mean Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue score	6 months