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.

PURPOSE: To evaluate the prevalence and prognostic value of sarcopenia in patients diagnosed with hematological cancer diseases.

Study Overview

• Status: Active, not recruiting
• Conditions: Lymphoma; Acute Myeloid Leukemia; Myelodysplastic Syndromes; Hematologic Diseases; Acute Lymphoid Leukemia

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 Type: Observational
• Enrollment (Estimated): 216

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark
    • Rigshospitalet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with malignant lymphomas, acute leukaemia and multiple myeloma referred to treatment.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospitalization duration	Total number days in hospital	1 year post treatment
Disease free survival	Risk of disease progression	1 year post treatment
Overall survival	Risk of mortality from any-cause	1 year post treatment
Change in appendicular lean mass	Dual-energy X-ray Absorptiometry (DXA) scan	Baseline and 6 after treatment start
Change in whole body fat percentage	Dual-energy X-ray Absorptiometry (DXA) scan	Baseline and 6 months after treatment start
Change in visceral fat mass	Dual-energy X-ray Absorptiometry (DXA) scan	Baseline and 6 months after treatment start
Change in bone mineral density	Dual-energy X-ray Absorptiometry (DXA) scan	Baseline and 6 months after treatment start
Change in bone mineral content	Dual-energy X-ray Absorptiometry (DXA) scan	Baseline and 6 months after treatment start
Change in walking capacity	Maximum 10 meter walking speed	Baseline and 6 months after treatment start
Change in lower body physical function	30 seconds Sit-To-Stand test	Baseline and 6 months after treatment start
Change in maximum leg power	Leg extensor power test (Nottingham Power Rig)	Baseline and 6 months after treatment start
Change in hand grip strength	Maximum strength test by handgrip dynamometer	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.	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..	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.	Baseline and 6 months after treatment start
Change in body fat percentage	Bioelectrical Impedance Analyzer	Baseline and 6 months after treatment start
Change in fat mass	Bioelectrical Impedance Analyzer	Baseline and 6 months after treatment start
Change in fat-free mass	Bioelectrical Impedance Analyzer	Baseline and 6 months after treatment start
Change in muscle mass	Bioelectrical Impedance Analyzer	Baseline and 6 months after treatment start
Change in bone mass	Bioelectrical Impedance Analyzer	Baseline and 6 months after treatment start
Change in total body water	Bioelectrical Impedance Analyzer	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.	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.	Baseline and 6 months after treatment start

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Estimated): October 30, 2025
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: November 8, 2021
• First Submitted That Met QC Criteria: December 3, 2021
• First Posted (Actual): December 9, 2021

Study Record Updates

• Last Update Posted (Actual): August 11, 2025
• Last Update Submitted That Met QC Criteria: August 5, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Patient reported outcomes; Complications; Muscle strength; Physical function; Muscle mass; Hematological cancer diseases
• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Bone Marrow Diseases; Leukemia; Leukemia, Lymphoid; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Myelodysplastic Syndromes; Hematologic Diseases
• Other Study ID Numbers: MuscleLab2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Not provided

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