Muscle Dysfunction in Patients With Haematological Diseases

Sponsor

Rigshospitalet, Denmark (Other)

Overall Status

Recruiting

CT.gov ID

NCT05150561

Collaborator

(none)

216

Enrollment

Location

25.7

Anticipated Duration (Months)

8.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hematologic Diseases Acute Myeloid Leukemia Acute Lymphoid Leukemia Myelodysplastic Syndromes Lymphoma

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 Design

Study Type:

Observational

Anticipated Enrollment :

216 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Nov 8, 2021

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Hospitalization duration [1 year post treatment]
Total number days in hospital
Disease free survival [1 year post treatment]
Risk of disease progression
Overall survival [1 year post treatment]
Risk of mortality from any-cause
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 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 walking capacity [Baseline and 6 months after treatment start]
Maximum 10 meter walking speed
Change in lower body physical function [Baseline and 6 months after treatment start]
30 seconds Sit-To-Stand test
Change in maximum leg power [Baseline and 6 months after treatment start]
Leg extensor power test (Nottingham Power Rig)
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 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 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 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
Change in fat-free mass [Baseline and 6 months after treatment start]
Bioelectrical Impedance Analyzer
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 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 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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