Muscle Dysfunction in Patients With Haematological Diseases

N/AActive Not RecruitingNCT05150561

Rigshospitalet, Denmark216 enrolled

Overview

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

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

216

Conditions

Hematologic Diseases Acute Myeloid Leukemia Acute Lymphoid Leukemia Myelodysplastic Syndromes Lymphoma

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Rigshospitalet

Copenhagen, Denmark

Outcomes

Primary Outcomes

Change in Whole body Lean body Mass

Dual-energy X-ray Absorptiometry (DXA) scan

Time frame: Baseline and 6 months after treatment start

Secondary Outcomes

Hospitalization duration

Total number days in hospital

Time frame: 1 year post treatment

Disease free survival

Risk of disease progression

Time frame: 1 year post treatment

Overall survival

Risk of mortality from any-cause

Time frame: 1 year post treatment

Change in appendicular lean mass

Dual-energy X-ray Absorptiometry (DXA) scan

Time frame: Baseline and 6 after treatment start

Change in whole body fat percentage

Dual-energy X-ray Absorptiometry (DXA) scan

Time frame: Baseline and 6 months after treatment start

Change in visceral fat mass

Dual-energy X-ray Absorptiometry (DXA) scan

Time frame: Baseline and 6 months after treatment start

Change in bone mineral density

Dual-energy X-ray Absorptiometry (DXA) scan

Time frame: Baseline and 6 months after treatment start

Change in bone mineral content

Data from ClinicalTrials.gov

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Dual-energy X-ray Absorptiometry (DXA) scan

Time frame: Baseline and 6 months after treatment start

Change in walking capacity

Maximum 10 meter walking speed

Time frame: Baseline and 6 months after treatment start

Change in lower body physical function

30 seconds Sit-To-Stand test

Time frame: Baseline and 6 months after treatment start

Change in maximum leg power

Leg extensor power test (Nottingham Power Rig)

Time frame: Baseline and 6 months after treatment start

Change in hand grip strength

Maximum strength test by handgrip dynamometer

Time frame: 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.

Time frame: 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..

Time frame: 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.

Time frame: Baseline and 6 months after treatment start

Change in body fat percentage

Bioelectrical Impedance Analyzer

Time frame: Baseline and 6 months after treatment start

Change in fat mass

Bioelectrical Impedance Analyzer

Time frame: Baseline and 6 months after treatment start

Change in fat-free mass

Bioelectrical Impedance Analyzer

Time frame: Baseline and 6 months after treatment start

Change in muscle mass

Bioelectrical Impedance Analyzer

Time frame: Baseline and 6 months after treatment start

Change in bone mass

Bioelectrical Impedance Analyzer

Time frame: Baseline and 6 months after treatment start

Change in total body water

Bioelectrical Impedance Analyzer

Time frame: 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.

Time frame: 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.

Time frame: Baseline and 6 months after treatment start