WASPE Sleep Adjustment for Children Aged 0-4 Years Undergoing Radiotherapy: A Prospective Randomized Controlled Phase II Clinical Trial

Abstract Background Radiotherapy plays a crucial role in pediatric cancer treatment, but challenges exist in achieving precise positioning and irradiation, particularly in young patients. Anesthetics like propofol and chloral hydrate are commonly used, but their associated health risks necessitate exploration of alternative approaches. This study investigates the effectiveness of a novel sleep adjustment method in reducing sedative reliance during radiotherapy for children aged 0–4, aiming to enhance treatment safety and efficacy in this vulnerable population. Methods A randomized controlled Phase II clinical trial will enroll 140 pediatric patients who will be stratified 2:1 into the sleep adjustment group or the sedation group. The WASPE method, which includes watching videos, outdoor activities, stimulation to keep the child awake, playing with toys and eating snacks, will be used to induce deep sleep during radiotherapy in the sleep adjustment group, and the traditional sedation method will be used to deliver radiotherapy in the sedation group. The primary endpoint of the study is radiotherapy completion rate, with secondary endpoints including radiotherapy efficiency and accuracy metrics, quality of life assessments, biological markers of immune function and growth hormone levels, and safety assessments. Discussion This research aims to demonstrate the non-inferiority of the sleep adjustment approach versus standard sedation in radiotherapy completion rates for pediatric cancer patients. Detailed analyses focusing on radiotherapy completion rates, efficiency and accuracy metrics, quality of life assessments using the Pediatric Quality of Life Inventory, immune function indicators, growth hormone levels, and safety outcomes will provide valuable insights into the benefits of reducing sedative use in this context. By investigating innovative strategies to enhance the radiotherapy experience for young patients, this study contributes to advancing pediatric cancer care practices. Trial registration: The trial has been registered on ClinicalTrials.gov with identifier: NCT06443632 (registered May 30, 2024).