Status:
NOT_YET_RECRUITING
Lifestyle-modifying Interventions in Low-risk MDS Patients
Lead Sponsor:
Technische Universität Dresden
Conditions:
Myelodysplastic Syndromes
Eligibility:
All Genders
18+ years
Phase:
NA
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 c...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
April 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT05433805
Start Date
April 1 2023
End Date
October 1 2026
Last Update
June 27 2022
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