Feasibility of exercise training to address corticosteroid-induced changes in adolescents aged 10+ with lymphoma or leukemia during the first eight weeks of treatment: a pilot study.

Abstract

Introduction: Children and adolescents with hematological malignancies are at risk of adverse side effects from high-dose corticosteroid treatment during induction therapy. In this context, exercise and nutrition interventions are promising, physiologically grounded approaches but their feasibility and practical delivery during early intensive therapy remain unclear. Therefore, this prospective pilot randomized controlled trial was designed to evaluate the feasibility and preliminary effects of an exercise intervention and nutrition consultation in newly diagnosed patients.

Methods: Participants with leukemia or lymphoma, aged 10-17 years, were allocated to an 8-week exercise or sham control intervention (stratified randomization, 1:1 ratio, parallel groups) plus one-time nutrition counseling. Feasibility outcomes included recruitment, retention, adherence, safety, completion of assessments, and subjective feedback from patients and personnel involved in the study. Furthermore, repeated measures of physical performance, functional capacity, metabolic health, and body composition were used to explore baseline status and changes over time, after four and eight weeks of therapy.

Results: Six participants, two of which were allocated to the intervention group, completed the trial. Overall rates of consent (67%), training adherence (51%) and complete measures (70%) did not attain prespecified criteria (≥80%). Despite considerable variability, pilot data indicated reduced physical capacity and functioning inferior to healthy norms at baseline and over the course of the intervention including hand grip strength (ΔZ ± SD = -1.5 ± 1.4), cardiorespiratory fitness (steep ramp cycle ergometry peak power; ΔZ ± SD = -3.8 ± 1.2), and lower extremity muscle strength (5-times sit-to-stand test; ΔZ ± SD = 2.3 ± 2.0), while having mostly normal quadriceps muscle and abdominal fat thickness and erratic unfavorable metabolic states. No formal exploration of intervention effects was performed.

Discussion: Limited feasibility opposed continuation to a definite trial. Respective challenges observed may reflect particularities of early treatment, thus, substantial changes are advised for future protocols (e.g., towards a more adaptive trial design). Besides their limited generalizability and variability, pilot data suggests that adolescents undergoing induction therapy can experience intermittent deconditioning, while other outcomes were inconclusive. Thus, future exercise interventions should account for various objections to exercise participation, heterogeneous medical conditions, and potentially impaired physical capacity and functioning, especially during early therapy.

Clinical trial registration: https://drks.de/search/de/trial/DRKS00032259, identifier DRKS00032259.