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

June 22, 2022 updated by: Technische Universität Dresden

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Hematological improvement
Time Frame: 24 weeks
Hemoglobin level at the EOT visit, g/dL
24 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Evaluation of a priori metabolic parameters of MDS patients after combined physiotherapeutic and nutritive interventions
Time Frame: 6 months
Panel measurement, mg/dL
6 months
Evaluation of a priori inflammatory parameters of MDS patients after combined physiotherapeutic and nutritive interventions
Time Frame: 6 months
Panel measurement, ng/mL
6 months
Patients' adherence to therapy as an expression of the relevance of the lifestyle-modifying interventions in everyday life
Time Frame: 6 months
Diary analysis
6 months
Impact on quality of life
Time Frame: 6 months
QUALMS questionnaire
6 months
Impact on fatigue
Time Frame: 6 months
Mean Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue score
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Technische Universität Dresden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2023

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2026

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 23, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 22, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 27, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 27, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 22, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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