Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06773871

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

Led by Rigshospitalet, Denmark · Updated on 2025-08-19

36

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying how exercise might affect people with low-risk myeloid cancers or precursor conditions such as Clonal Cytopenia of Undetermined Significance (CCUS) and early-stage Myelodysplastic Syndrome (MDS). These conditions can lead to serious blood cancers like acute myeloid leukemia (AML) over time, especially in older adults. The study aims to explore if exercise can alter the bone marrow environment to delay or prevent disease progression, improve quality of life, and assess the feasibility and safety of such interventions. Participants will be randomly assigned to either continue their usual care or engage in a high-intensity interval exercise program totaling 180 minutes per week. This includes 12 weeks of supervised exercise followed by 12 weeks of non-supervised exercise. The trial is designed as a pilot to evaluate the practical aspects of conducting exercise interventions in this patient group and to observe potential biological and clinical effects. During the study, participants' attendance at exercise sessions, recruitment and retention rates, and any adverse events will be closely monitored over 24 weeks. Various health measures will be assessed, including aerobic capacity, muscle strength, body composition, blood biochemistry, immune markers, and patient-reported symptoms, at baseline, after the supervised exercise period, and after the non-supervised phase. These evaluations will help understand how exercise impacts disease-related factors and daily functioning in this population.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of lower-risk Myelodysplastic Syndrome or Clonal Cytopenia of Undetermined Significance (WHO 2022 Classification)
  • Written informed consent prior to study procedures
  • Performance status of 2 or less
  • Age over 18 years
Not Eligible

You will not qualify if you...

  • Unable to perform exercise due to physical disabilities or conditions such as arthrosis
  • Regularly exercising at moderate or high levels (not scoring "low" on physical activity questionnaire)
  • Unwilling to participate in the exercise intervention
  • Current use of metformin
  • Received chemotherapy, therapeutic radiation, or immunosuppressive therapy within the past year
  • Treatment with hypomethylating agents
  • Any absolute contraindication to cardiopulmonary exercise testing per American Heart Association and Danish Society of Cardiology guidelines
  • Hemoglobin levels below 5.5 mmol, or below 6.5 mmol with cardiac insufficiency or pacemaker
  • Dependent on 8 or more units of red blood cell transfusion in 16 weeks
  • Uncontrolled co-morbid medical conditions

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Exercise Intervention

Duration - 24 weeks

Participants complete weekly supervised exercise sessions for 12 weeks followed by 12 weeks of non-supervised exercise to assess feasibility and safety.

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

Trial Site Locations

Total: 2 locations

1

Rigshospitalet

Copenhagen, Denmark, Denmark, 2100

Not Yet Recruiting

2

Rigshospitalet

Copenhagen, Denmark

Actively Recruiting

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Research Team

K

Kirsten Gørnbæk, Professor

S

Stine Bitsch-Olsen, MSc

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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