Exercise for patients with low-risk myeloid cancers
Feasibility and Safety of Exercise in Patients With Low-risk (or Early-stage) Myeloid Cancers and Precursor Conditions (HemEx): a Randomized Controlled Pilot Trial
This study is testing if a special exercise program can help people with low-risk myeloid cancers stay healthy and possibly prevent their condition from getting worse.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 2 sites (Copenhagen, Denmark and 1 other locations) |
| Trial ID | NCT06773871 on ClinicalTrials.gov |
What this trial studies
This study investigates the feasibility and safety of an exercise intervention for patients diagnosed with low-risk myelodysplastic syndrome or clonal cytopenia of undetermined significance. The aim is to determine if exercise can serve as an early intervention to potentially prevent progression to more severe hematological cancers. Participants will be assessed for their ability to engage in physical activity, and those who meet the criteria will undergo an exercise regimen while being monitored for safety and effectiveness. The study is conducted at Rigshospitalet in Denmark.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with a diagnosis of low-risk myelodysplastic syndrome or clonal cytopenia of undetermined significance.
Not a fit: Patients who are physically unable to participate in exercise or those who have been regularly exercising prior to the study may not benefit.
Why it matters
Potential benefit: If successful, this approach could provide a non-invasive method to improve outcomes and potentially delay the progression of low-risk myeloid cancers.
How similar studies have performed: While exercise interventions have been explored in various cancer contexts, this specific approach for low-risk myeloid cancers is relatively novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Copenhagen, Denmark and 1 other locations
- Rigshospitalet — Copenhagen, Denmark, Denmark (Not_yet_recruiting)
- Rigshospitalet — Copenhagen, Denmark (Recruiting)
Study contacts
- Study coordinator: Kirsten Gørnbæk, Professor
- Email: kirsten.groenbaek@regionh.dk
- Phone: +4535456086
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.