Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06443632
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-05-30
Brief Title:
WASPE Sleep Adjustment for Children Aged 0-4 Years Undergoing Radiation Therapy
Sponsor:
Shandong Cancer Hospital and Institute
Organization:
Shandong Cancer Hospital and Institute
Study Overview
Official Title:
WASPE Sleep Adjustment for Children Aged 0-4 Years Undergoing Radiation Therapy A Prospective Randomized Controlled Phase II Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
Approximately 400000 children and adolescents globally and 22000 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 58 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 als 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 3059 of newly diagnosed pediatric cancer cases in China Therefore new methods for children aged 0-4 years are urgently needed Our centers 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 efficiency accuracy quality of life assessed via PedsQL immune function indicators and growth hormone levels and safety
Radiotherapy technicians are exploring new methods like psychological interventions as shown by Sonja et als 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 3059 of newly diagnosed pediatric cancer cases in China Therefore new methods for children aged 0-4 years are urgently needed Our centers 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 efficiency accuracy quality of life assessed via PedsQL immune function indicators and growth hormone levels and safety
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None