WASPE Sleep Adjustment for Children Aged 0-4 Years Undergoing Radiation Therapy

Pediatric Cancer Clinical Trial

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

Status Recruiting

Clinical Trial Summary

In China, pediatric tumors are the second leading cause of death in children. Radiotherapy is critical to the treatment of pediatric cancer, with about one-third of patients requiring it and nearly 50% for certain cancers, but young age and immature cognitive abilities pose challenges for precise positioning, leading to reliance on sedatives such as propofol or chloral hydrate, which pose health risks. Radiotherapy technicians are exploring new methods such as psychological interventions, but these methods are challenging for children aged 0-4, who account for a high proportion of pediatric cancer cases in China. Therefore, new methods for children aged 0-4 are urgently needed.

Clinical Trial Description

Approximately 400,000 children and adolescents globally and 22,000 children in China are diagnosed with malignancies each year, with pediatric tumors being the second leading cause of death in children. Radiotherapy is crucial for pediatric cancer treatment, with about one-third of patients requiring it and nearly 50% for certain cancers, but young age and immature cognitive abilities pose challenges for precise positioning and irradiation, leading to reliance on sedatives like propofol or chloral hydrate, which carry health risks. A retrospective study found a 5.8% incidence of cardiopulmonary complications with propofol-only anesthesia during pediatric radiotherapy, and guidelines and studies indicate that anesthetics pose rare but serious risks and may impact neurological development and learning abilities, highlighting the need to reduce sedative use to minimize side effects and improve long-term quality of life for pediatric cancer patients.

Radiotherapy technicians are exploring new methods like psychological interventions, as shown by Sonja et al.'s study where psychological intervention significantly reduced the need for sedation anesthesia in children undergoing radiotherapy, with better outcomes observed in girls. A 2023 multicenter study found that audiovisual-assisted radiotherapy (AVATAR) effectively reduced sedative use and improved quality of life and anxiety in 3-10-year-old children, with significant QoL improvements for children aged 5-7 and their parents. However, the application of these methods is challenging for children aged 0-4, who account for the highest proportion (30.59%) of newly diagnosed pediatric cancer cases in China. Therefore, new methods for children aged 0-4 years are urgently needed. Our center's prospective study (Oct 2021 - Oct 2022) with 28 children aged 0-4 found that the WASPE method combined with optical surface monitoring systems (OSMS) effectively guided young children to complete radiotherapy with reduced sedative use, with 69% of parents preferring the sleep adjustment method.

Based on promising findings, our study will randomize 0-4-year-old radiotherapy patients into sleep adjustment or conventional sedation groups to compare radiotherapy completion rates, improve quality of life (assessed via PedsQL™), and reduce parental anxiety (evaluated using SAS), all monitored by optical surface monitoring systems (OSMS). ;

Related Conditions & MeSH terms

• Pediatric Cancer

• NCT number: NCT06443632
• Study type: Interventional
• Source: Shandong Cancer Hospital and Institute
• Contact: Jinbo Yue, Dorcter
• Phone: 0531-67626442
• Email: jbyue@sdfmu.edu.cn
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2024
• Completion date: October 1, 2025