Hematologic DiseasesNCT05150561
Muscle Dysfunction in Patients With Haematological Diseases
An observational study of Hematologic Diseases and Acute Myeloid Leukemia, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
PURPOSE: To evaluate the prevalence and prognostic value of sarcopenia in patients diagnosed with hematological cancer diseases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematologic Diseases, Acute Myeloid Leukemia, Acute Lymphoid Leukemia
- How many people
- 216 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Oct 2023to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with malignant lymphomas, acute leukaemia and multiple myeloma referred to treatment.
Who may be able to join
- Patients diagnosed with malignant lymphomas, acute leukaemia and multiple myeloma referred to treatment at the Department of Haematology, Rigshospitalet.
Who cannot join
- Age: <18
- Pregnancy
- Physical or mental disabilities precluding test of muscle function
- Inability to read and understand Danish.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Prevalence and the Prognostic Value of Sarcopenia Among Patients With Haematological Cancer Diseases - A Prospective Observational Cohort Study.
PURPOSE: To evaluate the prevalence and prognostic value of sarcopenia in patients diagnosed with hematological cancer diseases.
Read the detailed description
Some patients diagnosed with malignant hematological diseases are faced with poor prognosis and thus must undergo a demanding course of treatment associated with severe deconditioning potentially leading to worse prognostic outcomes. It is currently not well-described, to what extend patients body composition at the point of diagnoses should be part of standard clinical evaluation in order to optimize therapy-efficacy. Recent findings suggest that pathophysiological alterations in skeletal muscle mass and function can have significant implications for the risk of disease progression and long-term prognosis.
- Conditions
- Hematologic Diseases, Acute Myeloid Leukemia, Acute Lymphoid Leukemia, Myelodysplastic Syndromes, Lymphoma
- Keywords
- Hematological cancer diseases, Muscle mass, Muscle strength, Complications, Patient reported outcomes, Physical function
- Medical subject headings
- Hematologic Diseases, Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Myelodysplastic Syndromes, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort I - Patients newly diagnosed with malignant lymphoma (n=72) | These patients will undergo two assessments: A baseline-assessment prior to treatment for the hematologic cancer disease and a follow-up assessment at 6 months after treatment start | |
| Cohort II - Patients newly diagnosed with acute leukaemia (n=72) | These patients will undergo two assessments: A baseline-assessment prior to treatment for the hematologic cancer disease and a follow-up assessment at 6 months after treatment start | |
| Cohort III - Patients newly diagnosed with multiple myeloma (n=72) | These patients will undergo two assessments: A baseline-assessment prior to treatment for the hematologic cancer disease and a follow-up assessment at 6 months after treatment start |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Whole body Lean body Mass
Dual-energy X-ray Absorptiometry (DXA) scan
Measured: Baseline and 6 months after treatment start
Secondary outcomes (23)
Hospitalization duration
Total number days in hospital
Measured: 1 year post treatment
Disease free survival
Risk of disease progression
Measured: 1 year post treatment
Overall survival
Risk of mortality from any-cause
Measured: 1 year post treatment
Change in appendicular lean mass
Dual-energy X-ray Absorptiometry (DXA) scan
Measured: Baseline and 6 after treatment start
Change in whole body fat percentage
Dual-energy X-ray Absorptiometry (DXA) scan
Measured: Baseline and 6 months after treatment start
Change in visceral fat mass
Dual-energy X-ray Absorptiometry (DXA) scan
Measured: Baseline and 6 months after treatment start
Change in bone mineral density
Dual-energy X-ray Absorptiometry (DXA) scan
Measured: Baseline and 6 months after treatment start
Change in bone mineral content
Dual-energy X-ray Absorptiometry (DXA) scan
Measured: Baseline and 6 months after treatment start
Change in walking capacity
Maximum 10 meter walking speed
Measured: Baseline and 6 months after treatment start
Change in lower body physical function
30 seconds Sit-To-Stand test
Measured: Baseline and 6 months after treatment start
Change in maximum leg power
Leg extensor power test (Nottingham Power Rig)
Measured: Baseline and 6 months after treatment start
Change in hand grip strength
Maximum strength test by handgrip dynamometer
Measured: Baseline and 6 months after treatment start
Change in inflammation markers
Blood values are registered from the patients hospital record in relation to assessments. C-reactive protein (CRP) and leucocytes are registered as they are inflammation markers.
Measured: Baseline and 6 months after treatment start
Change in creatinine
Blood values are registered from the patients hospital record in relation to assessments. Creatinine is registered due to their relation to muscle strength..
Measured: Baseline and 6 months after treatment start
Change in hemoglobin
Blood values are registered from the patients hospital record in relation to assessments. Hemoglobin is registered due to their relation to muscle strength.
Measured: Baseline and 6 months after treatment start
Change in body fat percentage
Bioelectrical Impedance Analyzer
Measured: Baseline and 6 months after treatment start
Change in fat mass
Bioelectrical Impedance Analyzer
Measured: Baseline and 6 months after treatment start
Change in fat-free mass
Bioelectrical Impedance Analyzer
Measured: Baseline and 6 months after treatment start
Change in muscle mass
Bioelectrical Impedance Analyzer
Measured: Baseline and 6 months after treatment start
Change in bone mass
Bioelectrical Impedance Analyzer
Measured: Baseline and 6 months after treatment start
Change in total body water
Bioelectrical Impedance Analyzer
Measured: Baseline and 6 months after treatment start
Change in health-related quality of life
European Organisation for Research and Treatment of Cancer Quality of LifeQuestionnaire, Version 3.0 Scores range from 0 to 100; a higher score represents a higher ("better") level of functioning, or a higher ("worse") level of symptoms.
Measured: Baseline and 6 months after treatment start
Change in physical activity level
The International Physical Activity Questionnaires, short form. The Questionnaires covers the frequency and duration of vigorous, moderate, and walking activities over the last 7 days, as well as a single-item question on weekday sitting. Using the instrument's scoring protocol, total weekly physical activity can be calculated to three levels of physical activity and the interpretation of the questionnaire can be categorized in low, moderate and high physical activity, based on the stated time and Metabolic Equivalent of Task (METs min/week) used in different types of activities.
Measured: Baseline and 6 months after treatment start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start1 Oct 2023
- Primary completion30 Oct 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic DiseasesStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jan Christensen, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05150561
- Sponsor's protocol ID
- MuscleLab2020
- Status last verified
- Aug 2026
- First submitted
- 8 Nov 2021
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not provided
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence and the Prognostic Value of Sarcopenia Among Patients With Haematological Cancer Diseases - A Prospective Observational Cohort Study.
- ClinicalTrials.gov ID
- NCT05150561
- Acronym / sponsor ID
- MuscleLab2020
- Conditions
- Hematologic Diseases, Acute Myeloid Leukemia, Acute Lymphoid Leukemia, Myelodysplastic Syndromes, Lymphoma
- Keywords
- Hematological cancer diseases, Muscle mass, Muscle strength, Complications, Patient reported outcomes, Physical function
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 9 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
PURPOSE: To evaluate the prevalence and prognostic value of sarcopenia in patients diagnosed with hematological cancer diseases.
Detailed description
Some patients diagnosed with malignant hematological diseases are faced with poor prognosis and thus must undergo a demanding course of treatment associated with severe deconditioning potentially leading to worse prognostic outcomes. It is currently not well-described, to what extend patients body composition at the point of diagnoses should be part of standard clinical evaluation in order to optimize therapy-efficacy. Recent findings suggest that pathophysiological alterations in skeletal muscle mass and function can have significant implications for the risk of disease progression and long-term prognosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort I - Patients newly diagnosed with malignant lymphoma (n=72) | – | –These patients will undergo two assessments: A baseline-assessment prior to treatment for the hematologic cancer disease and a follow-up assessment at 6 months after treatment start |
| Cohort II - Patients newly diagnosed with acute leukaemia (n=72) | – | –These patients will undergo two assessments: A baseline-assessment prior to treatment for the hematologic cancer disease and a follow-up assessment at 6 months after treatment start |
| Cohort III - Patients newly diagnosed with multiple myeloma (n=72) | – | –These patients will undergo two assessments: A baseline-assessment prior to treatment for the hematologic cancer disease and a follow-up assessment at 6 months after treatment start |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with malignant lymphomas, acute leukaemia and multiple myeloma referred to treatment.
Key inclusion criteria (1 listed)
- Patients diagnosed with malignant lymphomas, acute leukaemia and multiple myeloma referred to treatment at the Department of Haematology, Rigshospitalet.
Key exclusion criteria (4 listed)
- Age: <18
- Pregnancy
- Physical or mental disabilities precluding test of muscle function
- Inability to read and understand Danish.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Whole body Lean body Mass
Time frame: Baseline and 6 months after treatment start
Dual-energy X-ray Absorptiometry (DXA) scan
23 secondary outcomes
Hospitalization duration
Time frame: 1 year post treatment
Disease free survival
Time frame: 1 year post treatment
Overall survival
Time frame: 1 year post treatment
Change in appendicular lean mass
Time frame: Baseline and 6 after treatment start
Change in whole body fat percentage
Time frame: Baseline and 6 months after treatment start
Change in visceral fat mass
Time frame: Baseline and 6 months after treatment start
Change in bone mineral density
Time frame: Baseline and 6 months after treatment start
Change in bone mineral content
Time frame: Baseline and 6 months after treatment start
Change in walking capacity
Time frame: Baseline and 6 months after treatment start
Change in lower body physical function
Time frame: Baseline and 6 months after treatment start
Change in maximum leg power
Time frame: Baseline and 6 months after treatment start
Change in hand grip strength
Time frame: Baseline and 6 months after treatment start
Change in inflammation markers
Time frame: Baseline and 6 months after treatment start
Change in creatinine
Time frame: Baseline and 6 months after treatment start
Change in hemoglobin
Time frame: Baseline and 6 months after treatment start
Change in body fat percentage
Time frame: Baseline and 6 months after treatment start
Change in fat mass
Time frame: Baseline and 6 months after treatment start
Change in fat-free mass
Time frame: Baseline and 6 months after treatment start
Change in muscle mass
Time frame: Baseline and 6 months after treatment start
Change in bone mass
Time frame: Baseline and 6 months after treatment start
Change in total body water
Time frame: Baseline and 6 months after treatment start
Change in health-related quality of life
Time frame: Baseline and 6 months after treatment start
Change in physical activity level
Time frame: Baseline and 6 months after treatment start
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: No. Not provided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematologic Diseases and Acute Myeloid Leukemia, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Whole body Lean body Mass (time frame: Baseline and 6 months after treatment start). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.