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

December 26, 2025 updated by: Jinbo Yue, Shandong Cancer Hospital and Institute

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 0531
        • Department of Radiation Oncology, Shandong Cancer Hospital and Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 0-4 years, any sex.
  • Histologically confirmed malignant solid tumor indicated for external-beam radiotherapy.
  • Lansky performance status ≥ 70.
  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: 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.
Active Comparator: 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.
Drug: Chloral Hydrate
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Per-fraction radiotherapy completion without pharmacologic sedation (WASPE arm)
Time Frame: 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.
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).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiotherapy positioning accuracy (CBCT/OSMS)
Time Frame: 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).
Interfraction setup error is quantified using pre-treatment CBCT registration to the planning CT along lateral, longitudinal, and vertical axes. Intrafraction motion is assessed using real-time optical surface monitoring system (OSMS) tracking, including total deviation and beam-on deviation metrics. A 5-mm motion threshold is applied; persistent deviations trigger treatment pause, patient repositioning, and CBCT re-verification as clinically indicated.
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)
Time Frame: ≤ 3 days before radiotherapy and ≈ 7 days after completion
Peripheral blood samples analyzed by ELISA to quantify IgA/IgG/IgM; change from pre-RT to post-RT compared between groups.
≤ 3 days before radiotherapy and ≈ 7 days after completion
Serum growth hormone (GH)
Time Frame: ≤ 3 days before radiotherapy and ≈ 7 days after completion
Serum GH measured by chemiluminescent immunoassay; change from pre-RT to post-RT compared between groups.
≤ 3 days before radiotherapy and ≈ 7 days after completion
Safety (CTCAE v5.0)
Time Frame: During radiotherapy and ≈ 7 days post-RT
Incidence and severity of AEs/SAEs graded per CTCAE v5.0, plus treatment interruptions and rescue sedation use.
During radiotherapy and ≈ 7 days post-RT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong Cancer Hospital and Institute

Investigators

  • Principal Investigator: Jinbo Yue, Dorcter, Shandong Cancer Hospital and Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2024

Primary Completion (Actual)

June 1, 2025

Study Completion (Actual)

June 1, 2025

Study Registration Dates

First Submitted

May 30, 2024

First Submitted That Met QC Criteria

May 30, 2024

First Posted (Actual)

June 5, 2024

Study Record Updates

Last Update Posted (Estimated)

January 2, 2026

Last Update Submitted That Met QC Criteria

December 26, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SDZLEC2024-077-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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