Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2025-12-30 @ 12:50 AM
Study NCT ID:
NCT06443632
Status:
COMPLETED
Last Update Posted:
2025-08-05
First Post:
2024-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
WASPE Sleep Adjustment for Children Aged 0-4 Years Undergoing Radiation Therapy
Sponsor:
Shandong Cancer Hospital and Institute
Organization:
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:
COMPLETED
Status Verified Date:
2025-07
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:
This prospective, randomized controlled Phase II clinical trial aims to evaluate the feasibility and effectiveness of a behavioral sleep adjustment protocol (WASPE: Watching videos, Activities outdoors, Stimulation to stay awake, Playing with toys, Eating snacks) in pediatric patients undergoing radiotherapy. A total of 48 children aged 0-4 years with non-head-and-neck tumors were enrolled and allocated to either the WASPE sleep adjustment group or the sedation group. The primary outcome was the rate of radiotherapy completion without sedation in the WASPE group. Secondary outcomes included motion accuracy (CBCT and OSMS) and physiological biomarkers (IgA, IgG, IgM, GH). This study explores a non-pharmacological alternative to sedation in pediatric radiotherapy preparation.
Detailed Description:
This randomized controlled Phase II trial investigated a non-pharmacological behavioral strategy (WASPE) to assist radiotherapy (RT) delivery in children aged 0-4 years. The WASPE protocol involves Watching videos, engaging in Activities outdoors, Stimulation to stay awake, Playing with toys, and Eating snacks to encourage early wakefulness and natural sleep during RT sessions. Eligible patients were randomly assigned in a 2:1 ratio to the WASPE group or a standard sedation group. Children in the sedation group received oral or rectal chloral hydrate per institutional protocols.
All patients received image-guided intensity-modulated radiotherapy (IMRT). Pretreatment setup was verified using cone-beam CT (CBCT), and real-time motion was monitored using an optical surface monitoring system (OSMS). A motion threshold of 5 mm was enforced; if deviation exceeded this threshold and did not self-correct, treatment was paused and the patient was repositioned. If motion resolved spontaneously, treatment continued without interruption.
The primary outcome was the radiotherapy completion rate without sedation in the WASPE group. Secondary outcomes included: (1) inter- and intrafraction motion measured by CBCT and OSMS, and (2) changes in serum biomarkers of immunity (IgA, IgG, IgM) and endocrine function (growth hormone, GH) before and after RT. Although caregiver-requested crossover from the sedation group to the WASPE protocol occurred in some cases, all data were analyzed according to the initial group assignment.
This study aims to determine whether the WASPE method can serve as a feasible and effective alternative to sedation in very young children undergoing RT, with comparable positioning accuracy and minimal interference with physiological homeostasis.
All patients received image-guided intensity-modulated radiotherapy (IMRT). Pretreatment setup was verified using cone-beam CT (CBCT), and real-time motion was monitored using an optical surface monitoring system (OSMS). A motion threshold of 5 mm was enforced; if deviation exceeded this threshold and did not self-correct, treatment was paused and the patient was repositioned. If motion resolved spontaneously, treatment continued without interruption.
The primary outcome was the radiotherapy completion rate without sedation in the WASPE group. Secondary outcomes included: (1) inter- and intrafraction motion measured by CBCT and OSMS, and (2) changes in serum biomarkers of immunity (IgA, IgG, IgM) and endocrine function (growth hormone, GH) before and after RT. Although caregiver-requested crossover from the sedation group to the WASPE protocol occurred in some cases, all data were analyzed according to the initial group assignment.
This study aims to determine whether the WASPE method can serve as a feasible and effective alternative to sedation in very young children undergoing RT, with comparable positioning accuracy and minimal interference with physiological homeostasis.
Study Oversight
Has Oversight DMC:
False
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?: