Clinical trial NCT05150561: Muscle Dysfunction in Patients With Haematological Diseases
Official title: The Prevalence and the Prognostic Value of Sarcopenia Among Patients With Haematological Cancer Diseases - A Prospective Observational Cohort Study.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hematologic Diseases
Acute Myeloid Leukemia
Acute Lymphoid Leukemia
Myelodysplastic Syndromes
Lymphoma
Keywords: Hematological cancer diseases
Muscle mass
Muscle strength
Complications
Patient reported outcomes
Physical function
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2021-12-09
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with malignant lymphomas, acute leukaemia and multiple myeloma referred to treatment.

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Whole body Lean body Mass
timeFrame: Baseline and 6 months after treatment start
Secondary outcomes:
measure: Hospitalization duration
timeFrame: 1 year post treatment
measure: Disease free survival
timeFrame: 1 year post treatment
measure: Overall survival
timeFrame: 1 year post treatment
measure: Change in appendicular lean mass
timeFrame: Baseline and 6 after treatment start
measure: Change in whole body fat percentage
timeFrame: Baseline and 6 months after treatment start
measure: Change in visceral fat mass
timeFrame: Baseline and 6 months after treatment start
measure: Change in bone mineral density
timeFrame: Baseline and 6 months after treatment start
measure: Change in bone mineral content
timeFrame: Baseline and 6 months after treatment start
measure: Change in walking capacity
timeFrame: Baseline and 6 months after treatment start
measure: Change in lower body physical function
timeFrame: Baseline and 6 months after treatment start
measure: Change in maximum leg power
timeFrame: Baseline and 6 months after treatment start
measure: Change in hand grip strength
timeFrame: Baseline and 6 months after treatment start
measure: Change in inflammation markers
timeFrame: Baseline and 6 months after treatment start
measure: Change in creatinine
timeFrame: Baseline and 6 months after treatment start
measure: Change in hemoglobin
timeFrame: Baseline and 6 months after treatment start
measure: Change in body fat percentage
timeFrame: Baseline and 6 months after treatment start
measure: Change in fat mass
timeFrame: Baseline and 6 months after treatment start
measure: Change in fat-free mass
timeFrame: Baseline and 6 months after treatment start
measure: Change in muscle mass
timeFrame: Baseline and 6 months after treatment start
measure: Change in bone mass
timeFrame: Baseline and 6 months after treatment start
measure: Change in total body water
timeFrame: Baseline and 6 months after treatment start
measure: Change in health-related quality of life
timeFrame: Baseline and 6 months after treatment start
measure: Change in physical activity level
timeFrame: Baseline and 6 months after treatment start
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
References: