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

Primary Purpose

Myelodysplastic Syndromes

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Fasting-mimicking diet (FMD) and physiotherapy
Sponsored by
Technische Universität Dresden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myelodysplastic Syndromes focused on measuring Myelodysplastic syndrome, fasting-mimicking diet, physiotherapy, lifestyle modification, inflammation, metabolism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    FMD first

    Physiotherapy first

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

    Hematological improvement
    Hemoglobin level at the EOT visit, g/dL

    Secondary Outcome Measures

    Evaluation of a priori metabolic parameters of MDS patients after combined physiotherapeutic and nutritive interventions
    Panel measurement, mg/dL
    Evaluation of a priori inflammatory parameters of MDS patients after combined physiotherapeutic and nutritive interventions
    Panel measurement, ng/mL
    Patients' adherence to therapy as an expression of the relevance of the lifestyle-modifying interventions in everyday life
    Diary analysis
    Impact on quality of life
    QUALMS questionnaire
    Impact on fatigue
    Mean Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue score

    Full Information

    First Posted
    May 23, 2022
    Last Updated
    June 22, 2022
    Sponsor
    Technische Universität Dresden
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05433805
    Brief Title
    Lifestyle-modifying Interventions in Low-risk MDS Patients
    Acronym
    MDS-LIME
    Official Title
    Prospective Evaluation of Lifestyle-modifying Interventions on Disease Parameters, Inflammatory and Metabolic Processes in Low-risk MDS Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 2023 (Anticipated)
    Primary Completion Date
    April 2026 (Anticipated)
    Study Completion Date
    October 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Technische Universität Dresden

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Myelodysplastic Syndromes
    Keywords
    Myelodysplastic syndrome, fasting-mimicking diet, physiotherapy, lifestyle modification, inflammation, metabolism

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    36 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    FMD first
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    Physiotherapy first
    Arm Type
    Experimental
    Arm 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.
    Intervention Type
    Other
    Intervention Name(s)
    Fasting-mimicking diet (FMD) and physiotherapy
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Hematological improvement
    Description
    Hemoglobin level at the EOT visit, g/dL
    Time Frame
    24 weeks
    Secondary Outcome Measure Information:
    Title
    Evaluation of a priori metabolic parameters of MDS patients after combined physiotherapeutic and nutritive interventions
    Description
    Panel measurement, mg/dL
    Time Frame
    6 months
    Title
    Evaluation of a priori inflammatory parameters of MDS patients after combined physiotherapeutic and nutritive interventions
    Description
    Panel measurement, ng/mL
    Time Frame
    6 months
    Title
    Patients' adherence to therapy as an expression of the relevance of the lifestyle-modifying interventions in everyday life
    Description
    Diary analysis
    Time Frame
    6 months
    Title
    Impact on quality of life
    Description
    QUALMS questionnaire
    Time Frame
    6 months
    Title
    Impact on fatigue
    Description
    Mean Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue score
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 18-75 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) Non-transfusion dependent (NTD) per IWG 2018 criteria (≤2 blood transfusions within 16 weeks prior to inclusion in the study) ECOG≤2 Body mass index (BMI) ≥ 20 kg/m2 Written informed consent of the subject after clarification Exclusion Criteria: 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 simultaneous participation in another interventional clinical trial (including within the last 4 weeks before inclusion) 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)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ekaterina Balaian, Dr.
    Phone
    +4935145819493
    Email
    Ekaterina.Balaian@ukdd.de
    First Name & Middle Initial & Last Name or Official Title & Degree
    Katja Sockel, Dr.
    Phone
    +4935145815627
    Email
    katja.sockel@ukdd.de

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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