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

August 18, 2025 updated by: Kirsten Grønbæk, Rigshospitalet, Denmark

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Denmark
      • Copenhagen, Denmark
        • Recruiting
        • Rigshospitalet
      • Copenhagen, Denmark, 2100
        • Not yet recruiting
        • Rigshospitalet
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kirsten Grønbæk, Professor
        • Sub-Investigator:
          • Stine Bitsch-Olsen, MSc
        • Sub-Investigator:
          • Casper Simonsen, Phd, MSc
        • Sub-Investigator:
          • Stine Ulrik Mikkelsen, Phd, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
Usual care
Other: Control
Remain usual activity level
Experimental: Exercise intervention
High-intensity interval exercise (180 min/week)
Other: Exercise
Weekly supervised exercise for 12 weeks followed by 12 weeks of non-supervised exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From baseline until the end of12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
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
From baseline until end of intervention (24 weeks)
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.
From baseline until the end of intervention (24 weeks)
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.
From baseline until the end of intervention (24 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From baseline until the end of12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
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
From baseline until the end of12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
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
From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
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
From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
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
From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
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
From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
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)
From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
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
From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
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
From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
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
From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
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
From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
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
From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
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
From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
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
From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
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
From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
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
From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
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
From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
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
From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
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
From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
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
From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
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
From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
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
From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
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
From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
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
From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
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)
From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
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
From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
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
From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
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)
From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
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
From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
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)
From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.
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
From baseline until the end of 12 weeks of supervised exercise. And after 12 weeks of no supervised exercise.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

January 8, 2025

First Submitted That Met QC Criteria

January 8, 2025

First Posted (Actual)

January 14, 2025

Study Record Updates

Last Update Posted (Actual)

August 19, 2025

Last Update Submitted That Met QC Criteria

August 18, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-23022425

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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