Lifestyle-modifying Interventions in Low-risk MDS Patients

NCT ID: NCT05433805

Last Updated: 2022-06-27

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-30
• Study Completion Date: 2026-10-31

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.

Conditions

Myelodysplastic Syndromes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

FMD first

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.

Group Type: EXPERIMENTAL

Fasting-mimicking diet (FMD) and physiotherapy

Intervention Type: 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.

Physiotherapy first

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.

Group Type: EXPERIMENTAL

Fasting-mimicking diet (FMD) and physiotherapy

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Technische Universität Dresden

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Ekaterina Balaian, Dr.

Role: CONTACT

Ekaterina.Balaian@ukdd.de

+4935145819493

Katja Sockel, Dr.

Role: CONTACT

katja.sockel@ukdd.de

+4935145815627

Other Identifiers

2020

Identifier Type: -

Identifier Source: org_study_id