Lifestyle-modifying Interventions in Low-risk MDS Patients

NCT05433805 | Not Yet Recruiting

• 1 other identifier: 2020
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

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

Keywords

Myelodysplastic syndrome; fasting-mimicking diet; physiotherapy; lifestyle modification; inflammation; metabolism

Outcome Measures

Primary Outcomes (1)

• Hematological improvement

  Hemoglobin level at the EOT visit, g/dL

  24 weeks

Secondary Outcomes (5)

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

  6 months

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

  6 months

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

  6 months

• Impact on quality of life

  6 months

• Impact on fatigue

  6 months

Study Arms (2)

FMD first

EXPERIMENTAL

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.

Other: Fasting-mimicking diet (FMD) and physiotherapy

Physiotherapy first

EXPERIMENTAL

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.

Other: Fasting-mimicking diet (FMD) and physiotherapy

Interventions

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.

FMD first; Physiotherapy first

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• ECOG≤2
• Body mass index (BMI) ≥ 20 kg/m2
• Written informed consent of the subject after clarification

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Technische Universität Dresden: lead

MeSH Terms

Conditions

Myelodysplastic Syndromes; Inflammation

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ekaterina Balaian, Dr.

CONTACT

+4935145819493; Ekaterina.Balaian@ukdd.de

Katja Sockel, Dr.

CONTACT

+4935145815627; katja.sockel@ukdd.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2022
• First Posted: June 27, 2022
• Study Start: April 1, 2023
• Primary Completion: April 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: June 27, 2022

Record last verified: 2022-06