WASPE Sleep Adjustment for Children Aged 0-4 Years Undergoing Radiation Therapy: A Prospective Randomized Controlled Phase II Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Per-fraction radiotherapy completion without pharmacologic sedation (WASPE arm)
研究概览
简要总结
This prospective, randomized controlled feasibility 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.
详细描述
This is a prospective, randomized, open-label, pragmatic feasibility trial comparing a structured behavioral sleep-adjustment protocol (WASPE) with standard pharmacologic sedation to support radiotherapy (RT) delivery in children 0-4 years. Eligible patients have non-head-and-neck solid tumors indicated for external-beam RT and are randomized 2:1 to WASPE or sedation. To focus on children who typically require assistance to complete daily RT, those able to maintain treatment position without assistance are excluded.
The WASPE workflow is caregiver-guided and begins ≥3 days before RT to build sleep pressure: early wake (≈06:00-07:00), late bedtime (≈22:00-23:00), and RT scheduled 14:00-16:00 to coincide with a natural nap; familiarization with the treatment environment is encouraged. During treatment, motion is monitored with an optical surface monitoring system (OSMS) using a 5-mm threshold; if deviation exceeds the threshold and does not self-correct, irradiation is paused, the child is repositioned, and alignment is re-verified with CBCT. The control arm receives chloral hydrate 30-50 mg/kg (max 1 g) orally or rectally ~30 minutes before treatment per institutional protocol with continuous cardiorespiratory monitoring. Rescue sedation may be used as medically necessary and is recorded; caregiver-requested crossover from the sedation arm to WASPE is permitted.
Pre-treatment CBCT is registered to the planning CT at each fraction to correct set-up error. Real-time surface tracking is performed with OSMS.
The primary outcome is the per-fraction sedation-free completion rate in the WASPE arm, evaluated for non-inferiority to a prespecified performance target (95% with a 2% margin; lower 95% CI > 93%). Secondary outcomes include inter- and intrafraction displacement (CBCT/OSMS), serum IgA/IgG/IgM and growth hormone measured ≤3 days before RT and ≈7 days after completion, and safety per CTCAE v5.0 (including treatment interruptions and rescue sedation).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- — 至 4 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 0-4 years, any sex.
- •Histologically confirmed malignant solid tumor indicated for external-beam radiotherapy.
- •Lansky performance status ≥
- •Expected survival ≥ 3 months.
- •Adequate organ function within 14 days prior to enrollment, as determined by the investigator.
- •Parent(s)/legal guardian(s) able and willing to follow the WASPE instructions and provide written informed consent.
- •Clinical expectation that pharmacologic sedation or a structured behavioral intervention (e.g., WASPE) would otherwise be needed to complete radiotherapy.
排除标准
- •Ability to maintain treatment position without assistance (i.e., child already tolerates RT without sedation/behavioral intervention).
- •Head and neck tumors requiring thermoplastic mask immobilization incompatible with OSMS in our workflow.
- •Sleep disorders or central nervous system dysfunction affecting sleep-wake regulation or protocol compliance.
- •Clinically significant growth retardation or immunologic impairment judged by the investigator.
- •Severe or uncontrolled systemic disease or infection that could interfere with participation.
- •Contraindication or known allergy to chloral hydrate.
- •Any other condition that, in the investigator's judgment, would preclude safe participation or reliable assessment of outcomes.
研究组 & 干预措施
WASPE Sleep Adjustment Protocol
Parents are instructed to implement the WASPE protocol (Watching videos, Activities outdoors, Stimulation to stay awake, Playing with toys, and Eating snacks) to keep the child awake from morning until the scheduled RT slot (14:00-16:00), thereby inducing natural deep sleep during RT without pharmacologic sedation. Treatment setup is verified with CBCT and monitored in real time using OSMS with a 5-mm motion threshold.
干预措施: WASPE Sleep Adjustment Protocol (Behavioral)
Sedation
Oral or rectal chloral hydrate (typically 30-50 mg/kg, maximum 1 g) administered approximately 30 minutes before each RT fraction per institutional pediatric sedation protocol. Vital signs are monitored continuously. CBCT and OSMS are used as in the experimental arm.
干预措施: Chloral Hydrate (Drug)
结局指标
主要结局
Per-fraction radiotherapy completion without pharmacologic sedation (WASPE arm)
时间窗: From the first radiotherapy fraction through completion of the radiotherapy course (all scheduled fractions), with final assessment at the end of radiotherapy (typically within 2-8 weeks from treatment initiation).
A fraction is counted successful if completed as planned without rescue sedation. The primary analysis evaluates non-inferiority to a prespecified performance target of 95% with a 2% margin; non-inferiority is concluded if the lower bound of the 95% CI exceeds 93.0% (one-sided α = 0.025). Fractions are analyzed under an intention-to-treat framework at the fraction level.
次要结局
- Radiotherapy positioning accuracy (CBCT/OSMS)(From the first radiotherapy fraction through completion of the radiotherapy course, with final assessment at the end of radiotherapy (typically within 2-8 weeks from treatment initiation).)
- Serum immunoglobulins (IgA, IgG, IgM)(≤ 3 days before radiotherapy and ≈ 7 days after completion)
- Serum growth hormone (GH)(≤ 3 days before radiotherapy and ≈ 7 days after completion)
- Safety (CTCAE v5.0)(During radiotherapy and ≈ 7 days post-RT)
研究者
Jinbo Yue
Director of Radiation Oncology Department
Shandong Cancer Hospital and Institute