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Trial record 11 of 12 for:    QUALMS

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

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

Tracking Information
First Submitted Date  ICMJE May 23, 2022
First Posted Date  ICMJE June 27, 2022
Last Update Posted Date June 27, 2022
Estimated Study Start Date  ICMJE April 2023
Estimated Primary Completion Date April 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 22, 2022)
Hematological improvement [ Time Frame: 24 weeks ]
Hemoglobin level at the EOT visit, g/dL
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 22, 2022)
  • Evaluation of a priori metabolic parameters of MDS patients after combined physiotherapeutic and nutritive interventions [ Time Frame: 6 months ]
    Panel measurement, mg/dL
  • Evaluation of a priori inflammatory parameters of MDS patients after combined physiotherapeutic and nutritive interventions [ Time Frame: 6 months ]
    Panel measurement, ng/mL
  • Patients' adherence to therapy as an expression of the relevance of the lifestyle-modifying interventions in everyday life [ Time Frame: 6 months ]
    Diary analysis
  • Impact on quality of life [ Time Frame: 6 months ]
    QUALMS questionnaire
  • Impact on fatigue [ Time Frame: 6 months ]
    Mean Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue score
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lifestyle-modifying Interventions in Low-risk MDS Patients
Official Title  ICMJE Prospective Evaluation of Lifestyle-modifying Interventions on Disease Parameters, Inflammatory and Metabolic Processes in Low-risk MDS Patients
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Myelodysplastic Syndromes
Intervention  ICMJE 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.

Study Arms  ICMJE
  • 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.

    Intervention: Other: Fasting-mimicking diet (FMD) and physiotherapy
  • 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.

    Intervention: Other: Fasting-mimicking diet (FMD) and physiotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 22, 2022)
36
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2026
Estimated Primary Completion Date April 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ekaterina Balaian, Dr. +4935145819493 Ekaterina.Balaian@ukdd.de
Contact: Katja Sockel, Dr. +4935145815627 katja.sockel@ukdd.de
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05433805
Other Study ID Numbers  ICMJE 2020
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party Technische Universität Dresden
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Technische Universität Dresden
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Technische Universität Dresden
Verification Date June 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP