Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:25 AM
Ignite Modification Date:
2025-12-25 @ 3:25 AM
NCT ID:
NCT05433805
Eligibility Criteria:
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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05433805
Study Brief:
Protocol Section:
NCT05433805