Muscle Dysfunction in Patients With Haematological Diseases

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05150561
• Other study ID #: MuscleLab2020
• Status: Recruiting
• Start date: November 8, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: December 2021
• Source: Rigshospitalet, Denmark
• Contact: Jan Christensen, PhD
• Phone: 004535458511
• Email: jan.christensen.02[@]regionh.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 216
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Lymphoid Leukemia
• Acute Myeloid Leukemia
• Hematologic Diseases
• Leukemia
• Leukemia, Lymphoid
• Lymphoma
• Myelodysplastic Syndromes
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

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