Accepted for/Published in: JMIR Research Protocols
Date Submitted: Sep 10, 2021
Date Accepted: Feb 7, 2022
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Dexamethasone-induced sarcopenia and physical frailty in children with acute lymphoblastic leukemia: Protocol for a prospective cohort study
ABSTRACT
Background:
During treatment for pediatric acute lymphoblastic leukemia (ALL), children receive high doses of dexamethasone for its apoptotic effect on leukemia cells, however muscle atrophy is a well-known serious side-effect. Muscle atrophy (loss of muscle mass) accompanied by decreased muscle strength may lead to a generalized impaired skeletal muscle state called sarcopenia. Loss of muscle mass is also an indicator of physical frailty: a state of increased vulnerability, which is characterized by co-occurrence of low muscle mass, muscle weakness, fatigue, slow walking speed and low physical activity. Both sarcopenia and physical frailty are related to increased risk of infections, hospitalizations and decreased survival in children with chronic diseases.
Objective:
The aims of this study are to estimate the occurrence of sarcopenia and physical frailty in children during ALL maintenance therapy, to evaluate the effect of administering dexamethasone and to explore determinants associated with these outcomes.
Methods:
This prospective study is being pursued within the framework of the DexaDays-2: a randomized controlled trial on neurobehavioral side effects in pediatric ALL patients. One hundred and five children (3-18 years) undergoing ALL maintenance treatment at the Princess Máxima Center for pediatric oncology, are included in this study. Sarcopenia/frailty assessments are performed before and just after a 5-day dexamethasone course. A subset of 50 children participating in the DexaDays-2 trial because of severe dexamethasone-induced neuro-behavioral problems, were assessed at three additional timepoints.
Results:
Patient accrual started in 2018 and was finalized in spring 2021. From autumn 2021 onwards final data analyses will be performed.
Conclusions:
This first study combining parameters of sarcopenia and physical frailty, is of importance because these conditions can seriously complicate continuation of ALL therapy, independence in physical functioning, reaching motor mile stones and participating in daily life activities. The results will provide knowledge of these complications, the association between dexamethasone-treatment and muscle loss and other components of frailty, and therefore insights on the severity of this side-effect. Through exploring potential determinants which may be associated with sarcopenia and physical frailty, we may be able to identify children at risk at an earlier stage and provide timely interventions.
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