Muscle Dysfunction in Patients With Haematological Diseases

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

Detailed Description
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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.

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

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

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort I - Patients newly diagnosed with malignant lymphoma (n=72)<br>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)<br>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)<br>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?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hematological cancer diseases, Muscle mass, Muscle strength, Complications, Patient reported outcomes, Physical function