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NCT Number: NCT06773871

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

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 inactivity is associated with multiple solid cancers, and it has been suggested that exercise can prevent for example certain colon- or breast cancers. Studies in mice have shown that exercise can reduce tumor size and incidence of solid cancers, and different mechanisms have been suggested including increased immune cell infiltration, reduced systemic inflamma-tion, and metabolic changes. The mechanisms of disease progression of pre-leukemia and MDS are complex and probably multifactorial, but recent studies suggest that components such as natural killer cells, adipocytes, and inflammatory substances in the bone marrow mi-croenvironment play a crucial role; factors that exercise may modulate. In addition, recent stud-ies have shown that increased bone marrow adipose tissue (BMAT) may create a microenvi-ronment that supports the expansion of leukemic cells and thus may facilitate disease progres-sion, and earlier studies among healthy, younger individuals have shown that exercise can reduce the amount of BMAT significantly.

Therefore, the investigators hypothesize that exercise may prevent or delay the progression from pre-leukemia to leukemia by altering the microenvironment in the bone marrow.

The purpose with this clinical, pilot trial where patients with the preleukemic condition CCUS or early stage of leukemia (i.e., lower-risk MDS) will undergo an individualized exercise interven-tion, is to investigate:

1. whether an exercise intervention and the trial set-up, are feasible and safe in this cohort, 2. potential mechanisms in leukemogenesis affected by exercise in controlling dis-ease progression, 3. and the effect hereof on quality of life and activities of daily living. The above will inform the decision-making on designing a larger randomized, controlled trial.

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Key information

Conditions

Myelodysplastic Syndrome Bone Marrow Diseases Cytopenia Hematologic Diseases Hemic and Lymphatic Diseases Myelodysplastic Syndromes

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rigshospitalet, Copenhagen, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Other

Weekly supervised exercise for 12 weeks followed by 12 weeks of non-supervised exercise

Control

Other

Remain usual activity level

Primary outcomes

  1. Exercise feasibility: Exercise sessions attendance

    Time frame: From baseline until the end of12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.

    The number of attended exercise training sessions relative to the number of planned exercise sessions

  2. Exercise feasibility: Recruitment, refusal, and retention rates

    Time frame: From baseline until end of intervention (24 weeks)

    The number of patients recruited to the study, the number of patients who refused to be enrolled in the study, the number of participants that completed the study

  3. Incidence of Adverse Events (AEs)

    Time frame: From baseline until the end of intervention (24 weeks)

    AE will be recorded during trial assessment visits and through medical records. This procedure will concern any AE during the trial period. We will collect patients' self-report of AEs for each trial visit and telephone interview, which may have occurred since the last trial visit and telephone interview.

  4. Incidence of Serious Adverse Events (SAEs)

    Time frame: From baseline until the end of intervention (24 weeks)

    SAE will be recorded during trial assessment visits and through medical records. This procedure will concern any SAE during the trial period. We will collect patients' self-report of SAEs for each trial visit and telephone interview, which may have occurred since the last trial visit and telephone interview.

Secondary outcomes

  1. Changes in peak oxygen consumption (VO2 peak)

    Time frame: From baseline until the end of12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.

    Changes in VO2peak assessed during an incremental exercise test to volitional exhaustion on a bicycle ergometer

  2. Changes in Aerobic Capacity: Peak power output

    Time frame: From baseline until the end of12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.

    Changes in peak power output assessed during an incremental exercise test to volitional exhaustion on a bicycle ergometer

  3. Changes in Muscle strength: Hand grip strength

    Time frame: From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.

    Changes in hand grip strength, assessed using a dynamometer

  4. Changes in Functional performance: Habitual gait speed

    Time frame: From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.

    Changes in habitual gait speed

  5. Changes in Functional performance: 30 seconds Sit-to-stand

    Time frame: From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.

    Changes in the number of stands from sitting position that can be performed during 30 seconds

  6. Changes in Body composition and anthropometrics: Body mass

    Time frame: From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.

    Changes in body mass

  7. Changes in Body composition and anthropometrics: Total lean mass

    Time frame: From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.

    Changes in total lean mass assessed by dual energy x-ray absorptiometry (DXA)

  8. Changes in Body composition and anthropometrics: Total fat mass

    Time frame: From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.

    Changes in total fat mass assessed by DXA

  9. Changes in Body composition and anthropometrics: Bone mineral density

    Time frame: From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.

    Changes in bone mineral density assessed by DXA

  10. Changes in Blood biochemistry: C-reactive protein

    Time frame: From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.

    Changes in resting C-reactive protein levels in blood

  11. Changes in Blood biochemistry: Insulin

    Time frame: From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.

    Changes in resting insulin blood levels

  12. Changes in Blood biochemistry: Glucose

    Time frame: From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.

    Changes in resting glucose blood levels

  13. Changes in Blood biochemistry: Triglycerides

    Time frame: From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.

    Changes in resting triglycerides blood levels

  14. Changes in Blood biochemistry: LDL-Cholesterol

    Time frame: From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.

    Changes in resting LDL-cholesterol blood levels

  15. Changes in Blood biochemistry: HDL-Cholesterol

    Time frame: From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.

    Changes in resting HDL-cholesterol blood levels

  16. Changes in Blood biochemistry: Total Cholesterol

    Time frame: From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.

    Changes in resting Cholesterol blood levels

  17. Changes in Blood biochemistry: HbA1c

    Time frame: From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.

    Changes in resting HbA1c blood levels

  18. Changes in Blood biochemistry: total bilirubin

    Time frame: From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.

    Changes in resting total bilirubin blood levels

  19. Changes in Blood biochemistry: Vitamin D (25-Hydroxy-Vitamin D(D3+D2))

    Time frame: From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.

    Changes in resting Vitamin D (25-Hydroxy-Vitamin D(D3+D2)) blood levels

  20. Changes in Blood biochemistry: insulin growth factor 1 (IGF-1)

    Time frame: From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.

    Changes in resting insulin growth factor 1 (IGF-1) blood levels

  21. Changes in Blood biochemistry: human growth hormone (HGH)

    Time frame: From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.

    Changes in resting human growth hormone (HGH) blood levels

  22. Changes in Blood biochemistry: sex hormones (estrogen, progesterone and testosterone)

    Time frame: From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.

    Changes in resting human sex hormones (estrogen, progesterone and testosterone)blood levels

  23. Changes in Cytokine levels in blood: Interleukin-6

    Time frame: From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.

    Changes in resting Interleukin-6 blood levels

  24. Changes in Cytokine levels in blood: Tumor-necrosis-factor alpha (TNFalpha)

    Time frame: From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.

    Changes in resting TNFalpha blood levels

  25. Changes in Patient-reported symptomatic adverse events

    Time frame: From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.

    Patient-reported symptomatic adverse events, assessed using the using the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

  26. Inflammatory markers in Bone marrow (BM) and peripheral blood

    Time frame: From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.

    Changes in the inflammatory markers INF-γ, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12p70, IL-13, TNF-α, adiponectin and leptin in bone marrow aspirate and peripheral blood

  27. Regulate the immune cell composition in the BM

    Time frame: From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.

    Changes in immune cell composition in the BM measured by flow cytometry

  28. Change the variant allele frequency (VAF)

    Time frame: From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.

    Changes in VAF detected with targeted next generation sequencing (NGS)

  29. Alter the composition of BMAT

    Time frame: From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.

    Changes in BMAT composition

  30. Ifluence on the cytopenia(s)

    Time frame: From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.

    Changes in blood cell counts (i.e., hemoglobin, white blood cell count, platelet count, absolute neutrophil count, lymphocyte count, basophil count, eosinophil count, monocyte count, reticulocyte count, peripheral blood blast count, red cell)

  31. Changes in Blood biochemistry: Lactate dehydrogenase (LDH)

    Time frame: From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.

    Changes in resting Lactate dehydrogenase (LDH) blood levels

Study contacts

Contact information is provided by the study sponsor or research team.

Kirsten Gørnbæk, Professor

CONTACT

[email protected]

+4535456086

Stine Bitsch-Olsen, MSc

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

Feasibility and Safety of Exercise in Patients With Low-risk (or Early-stage) Myeloid Cancers and Precursor Conditions (HemEx): a Randomized Controlled Pilot Trial

Acronym: HemEx

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 14, 2025
Registry last updated
Aug 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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