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

• ClinicalTrials.gov Identifier: NCT05433805
• Recruitment Status: Not yet recruiting
• First Posted: June 27, 2022
• Last Update Posted: June 27, 2022
• Sponsor: Technische Universität Dresden
• Information provided by (Responsible Party): Technische Universität Dresden

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Myelodysplastic Syndromes	Other: Fasting-mimicking diet (FMD) and physiotherapy	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Prospective Evaluation of Lifestyle-modifying Interventions on Disease Parameters, Inflammatory and Metabolic Processes in Low-risk MDS Patients
• Estimated Study Start Date: April 2023
• Estimated Primary Completion Date: April 2026
• Estimated Study Completion Date: October 2026

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	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.
Experimental: 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.	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.

Outcome Measures

Primary Outcome Measures :

1. Hematological improvement [ Time Frame: 24 weeks ]
   Hemoglobin level at the EOT visit, g/dL

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Contacts

Contact: Ekaterina Balaian, Dr.; +4935145819493; Ekaterina.Balaian@ukdd.de

Contact: Katja Sockel, Dr.; +4935145815627; katja.sockel@ukdd.de

Sponsors and Collaborators

Technische Universität Dresden

More Information

• Responsible Party: Technische Universität Dresden
• ClinicalTrials.gov Identifier: NCT05433805
• Other Study ID Numbers: 2020
• First Posted: June 27, 2022
• Last Update Posted: June 27, 2022
• Last Verified: June 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Technische Universität Dresden:

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

Additional relevant MeSH terms:

Preleukemia; Myelodysplastic Syndromes; Bone Marrow Diseases; Hematologic Diseases; Precancerous Conditions; Neoplasms