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Feasibility and Safety of Exercise in Patients With Low-risk Myeloid Cancers and Precursor Conditions

RecruitingNAAges 18 Years - anyAllCopenhagen University Hospital, Rigshospitalet
NCT06773871 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Somatic mutations as seen in myeloid malignancies can also be detected in healthy, elderly individuals (clonal hematopoiesis of indeterminate potential, CHIP), in patients with unex-plained cytopenia, that do not fulfill the criteria for myeloid malignancy (clonal cytopenia of un-determined significance, CCUS) It has been shown that these conditions predispose to hema-tological cancer. For patients with CCUS, it has been reported that in a 5-year period up to 50-90 % of the patients will progress to myelodysplastic syndrome (MDS) or acute myeloid leu-kemia (AML), both devastating diseases with poor outcomes, especially for the elderly popula-tion. There is currently no treatment available for patients with CCUS besides supporting agents. Since the somatic mutations can be detected up to 10 years before a diagnosis of MDS, it opens the potential for early intervention. Physical inactivit

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📋 Eligibility rules (as published)
Inclusion Criteria: * A diagnosis of either Lower-risk of Myelodysplastic Syndrome or Clonal Cytopenia of undetermined significance(WHO 2022 Classification) * Written informed consent prior to study procedures * Performance status ≤ 2 * Age \> 18 years old Exclusion Criteria: * Physically not able to undergo exercise intervention (e.g., arthrosis, physical disabilities) * Exercising on a regular basis (i.e., participants must score in the category "low" when screening with International Physical Activity Questionnaire-Short Form; IPAQ-SF27) * Unwillingness to undergo exercise intervention * Use of metformin * Treatment with chemotherapy, therapeutic radiation, or immunosuppressive therapy within the last year * Treatment with hypomethylating agents * Any absolute contraindication to undergo cardiopulmonary exercise testing according to working papers from American Heart Association and Danish Society of Cardiology * Hemoglobin levels \< 5.5 mmol OR \<6.5 mmol and simultaneous cardiac insufficiency OR pacemaker. * Blood transfusion-dependent ≥ 8 units of red blood cell transfusion in 16 weeks (IWG 2018-criteria) * Uncontrolled co-morbidity
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What it tests

  • Exercise
  • Control
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Where

2 sites
Rigshospitalet
Copenhagen, Denmark
Rigshospitalet
Copenhagen, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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