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Muscle Dysfunction in Patients With Haematological Diseases

The Prevalence and the Prognostic Value of Sarcopenia Among Patients With Haematological Cancer Diseases - A Prospective Observational Cohort Study.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05150561
Enrollment
216
Registered
2021-12-09
Start date
2023-10-01
Completion date
2026-12-01
Last updated
2026-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Lymphoid Leukemia, Acute Myeloid Leukemia, Hematologic Diseases, Lymphoma, Myelodysplastic Syndromes

Keywords

Hematological cancer diseases, Muscle mass, Muscle strength, Complications, Patient reported outcomes, Physical function

Brief summary

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.

Interventions

None listed

Sponsors

Rigshospitalet, Denmark
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

• Patients diagnosed with malignant lymphomas, acute leukaemia and multiple myeloma referred to treatment at the Department of Haematology, Rigshospitalet.

Exclusion criteria

* Age: \<18 * Pregnancy * Physical or mental disabilities precluding test of muscle function * Inability to read and understand Danish.

Design outcomes

Primary

MeasureTime frameDescription
Change in Whole body Lean body MassBaseline and 6 months after treatment startDual-energy X-ray Absorptiometry (DXA) scan

Secondary

MeasureTime frameDescription
Hospitalization duration1 year post treatmentTotal number days in hospital
Disease free survival1 year post treatmentRisk of disease progression
Overall survival1 year post treatmentRisk of mortality from any-cause
Change in appendicular lean massBaseline and 6 after treatment startDual-energy X-ray Absorptiometry (DXA) scan
Change in whole body fat percentageBaseline and 6 months after treatment startDual-energy X-ray Absorptiometry (DXA) scan
Change in visceral fat massBaseline and 6 months after treatment startDual-energy X-ray Absorptiometry (DXA) scan
Change in bone mineral densityBaseline and 6 months after treatment startDual-energy X-ray Absorptiometry (DXA) scan
Change in bone mineral contentBaseline and 6 months after treatment startDual-energy X-ray Absorptiometry (DXA) scan
Change in walking capacityBaseline and 6 months after treatment startMaximum 10 meter walking speed
Change in lower body physical functionBaseline and 6 months after treatment start30 seconds Sit-To-Stand test
Change in maximum leg powerBaseline and 6 months after treatment startLeg extensor power test (Nottingham Power Rig)
Change in hand grip strengthBaseline and 6 months after treatment startMaximum strength test by handgrip dynamometer
Change in inflammation markersBaseline and 6 months after treatment startBlood 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.
Change in creatinineBaseline and 6 months after treatment startBlood values are registered from the patients hospital record in relation to assessments. Creatinine is registered due to their relation to muscle strength..
Change in hemoglobinBaseline and 6 months after treatment startBlood values are registered from the patients hospital record in relation to assessments. Hemoglobin is registered due to their relation to muscle strength.
Change in body fat percentageBaseline and 6 months after treatment startBioelectrical Impedance Analyzer
Change in fat massBaseline and 6 months after treatment startBioelectrical Impedance Analyzer
Change in fat-free massBaseline and 6 months after treatment startBioelectrical Impedance Analyzer
Change in muscle massBaseline and 6 months after treatment startBioelectrical Impedance Analyzer
Change in bone massBaseline and 6 months after treatment startBioelectrical Impedance Analyzer
Change in total body waterBaseline and 6 months after treatment startBioelectrical Impedance Analyzer
Change in health-related quality of lifeBaseline and 6 months after treatment startEuropean 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.
Change in physical activity levelBaseline and 6 months after treatment startThe 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.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 15, 2026