Muscle Dysfunction in Patients With Haematological Diseases

Recruiting

• Conditions: Hematologic Diseases; Acute Myeloid Leukemia; Acute Lymphoid Leukemia; Myelodysplastic Syndromes; Lymphoma

• Registration Number: NCT05150561
• Lead Sponsor: Rigshospitalet, Denmark

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.

Study Timeline

• Study First Submitted: 2021-11-08
• Study First Submitted QC: 2021-12-03
• Study First Posted: 2021-12-09
• Study Start: 2023-10-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-02
• Last Update Posted: 2025-04-06
• Primary Completion: 2025-06-30
• Study Completion: 2026-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 216

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Whole body Lean body Mass	Baseline and 6 months after treatment start	Dual-energy X-ray Absorptiometry (DXA) scan

Secondary Outcome Measures

Name	Time	Method
Change in visceral fat mass	Baseline and 6 months after treatment start	Dual-energy X-ray Absorptiometry (DXA) scan
Change in bone mineral density	Baseline and 6 months after treatment start	Dual-energy X-ray Absorptiometry (DXA) scan
Change in bone mineral content	Baseline and 6 months after treatment start	Dual-energy X-ray Absorptiometry (DXA) scan
Change in body fat percentage	Baseline and 6 months after treatment start	Bioelectrical Impedance Analyzer
Change in fat mass	Baseline and 6 months after treatment start	Bioelectrical Impedance Analyzer
Disease free survival	1 year post treatment	Risk of disease progression
Change in lower body physical function	Baseline and 6 months after treatment start	30 seconds Sit-To-Stand test
Change in hand grip strength	Baseline and 6 months after treatment start	Maximum strength test by handgrip dynamometer
Change in inflammation markers	Baseline and 6 months after treatment start	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.
Change in hemoglobin	Baseline and 6 months after treatment start	Blood values are registered from the patients hospital record in relation to assessments. Hemoglobin is registered due to their relation to muscle strength.
Change in muscle mass	Baseline and 6 months after treatment start	Bioelectrical Impedance Analyzer
Change in bone mass	Baseline and 6 months after treatment start	Bioelectrical Impedance Analyzer
Change in fat-free mass	Baseline and 6 months after treatment start	Bioelectrical Impedance Analyzer
Overall survival	1 year post treatment	Risk of mortality from any-cause
Hospitalization duration	1 year post treatment	Total number days in hospital
Change in appendicular lean mass	Baseline and 6 after treatment start	Dual-energy X-ray Absorptiometry (DXA) scan
Change in whole body fat percentage	Baseline and 6 months after treatment start	Dual-energy X-ray Absorptiometry (DXA) scan
Change in walking capacity	Baseline and 6 months after treatment start	Maximum 10 meter walking speed
Change in maximum leg power	Baseline and 6 months after treatment start	Leg extensor power test (Nottingham Power Rig)
Change in total body water	Baseline and 6 months after treatment start	Bioelectrical Impedance Analyzer
Change in health-related quality of life	Baseline and 6 months after treatment start	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.
Change in creatinine	Baseline and 6 months after treatment start	Blood values are registered from the patients hospital record in relation to assessments. Creatinine is registered due to their relation to muscle strength..
Change in physical activity level	Baseline and 6 months after treatment start	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.

Trial Locations

Locations (1)

Rigshospitalet; 🇩🇰 Copenhagen, Denmark