Myelodysplastic SyndromesMDS-LIMENCT05433805
Lifestyle-modifying Interventions in Low-risk MDS Patients
A study testing Fasting-mimicking diet (FMD) and physiotherapy in people with Myelodysplastic Syndromes, run by Technische Universität Dresden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelodysplastic Syndromes
- What is being tested?
- Fasting-mimicking diet (FMD) and physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Apr 2023to Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Prospective Evaluation of Lifestyle-modifying Interventions on Disease Parameters, Inflammatory and Metabolic Processes in Low-risk MDS Patients
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
- Being tested
- Fasting-mimicking diet (FMD) and physiotherapy
- Keywords
- Myelodysplastic syndrome, fasting-mimicking diet, physiotherapy, lifestyle modification, inflammation, metabolism
- Medical subject headings
- Myelodysplastic Syndromes, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fasting-mimicking diet (FMD) and physiotherapyOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Fasting-mimicking diet (FMD) and physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hematological improvement
Hemoglobin level at the EOT visit, g/dL
Measured: 24 weeks
Secondary outcomes (5)
Evaluation of a priori metabolic parameters of MDS patients after combined physiotherapeutic and nutritive interventions
Panel measurement, mg/dL
Measured: 6 months
Evaluation of a priori inflammatory parameters of MDS patients after combined physiotherapeutic and nutritive interventions
Panel measurement, ng/mL
Measured: 6 months
Patients' adherence to therapy as an expression of the relevance of the lifestyle-modifying interventions in everyday life
Diary analysis
Measured: 6 months
Impact on quality of life
QUALMS questionnaire
Measured: 6 months
Impact on fatigue
Mean Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue score
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study startApr 2023 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelodysplastic SyndromesStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05433805
- Sponsor's protocol ID
- 2020
- Acronym
- MDS-LIME
- Status last verified
- Jun 2022
- First submitted
- 23 May 2022
- Last updated
- 27 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Lifestyle-modifying Interventions on Disease Parameters, Inflammatory and Metabolic Processes in Low-risk MDS Patients
- ClinicalTrials.gov ID
- NCT05433805
- Acronym / sponsor ID
- MDS-LIME / 2020
- Conditions
- Myelodysplastic Syndromes
- Keywords
- Myelodysplastic syndrome, fasting-mimicking diet, physiotherapy, lifestyle modification, inflammation, metabolism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- Apr 2023 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 27 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FMD first | Experimental | Other: Fasting-mimicking diet (FMD) and physiotherapyPatients 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. |
| Physiotherapy first | Experimental | Other: Fasting-mimicking diet (FMD) and physiotherapyPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fasting-mimicking diet (FMD) and physiotherapyFMD 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. | Other | FMD first, Physiotherapy first |
Primary outcome
Hematological improvement
Time frame: 24 weeks
Hemoglobin level at the EOT visit, g/dL
5 secondary outcomes
Evaluation of a priori metabolic parameters of MDS patients after combined physiotherapeutic and nutritive interventions
Time frame: 6 months
Evaluation of a priori inflammatory parameters of MDS patients after combined physiotherapeutic and nutritive interventions
Time frame: 6 months
Patients' adherence to therapy as an expression of the relevance of the lifestyle-modifying interventions in everyday life
Time frame: 6 months
Impact on quality of life
Time frame: 6 months
Impact on fatigue
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Fasting-mimicking diet (FMD) and physiotherapy in people with Myelodysplastic Syndromes, run by Technische Universität Dresden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ekaterina Balaian, Dr. (+4935145819493, Ekaterina.Balaian@ukdd.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hematological improvement (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2022.