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

NCT06443632 | Completed

• 1 other identifier: SDZLEC2024-077-01
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pediatric Cancer

Keywords

Pediatric cancer; Radiotherapy; Sleep adjustment

Outcome Measures

Primary Outcomes (1)

• Per-fraction radiotherapy completion without pharmacologic sedation (WASPE arm)

  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 Outcomes (4)

• 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

Study Arms (2)

WASPE Sleep Adjustment Protocol

EXPERIMENTAL

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

Sedation

ACTIVE COMPARATOR

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

Interventions

WASPE Sleep Adjustment Protocol BEHAVIORAL

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.

WASPE Sleep Adjustment Protocol

Chloral Hydrate DRUG

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.

Sedation

Eligibility Criteria

• Age: Up to 4 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shandong Cancer Hospital and Institute: lead

Study Sites (1)

Department of Radiation Oncology, Shandong Cancer Hospital and Institute

Jinan, Shandong, 0531, China

Location

Related Publications (14)

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MeSH Terms

Conditions

Neoplasms

Interventions

Chloral Hydrate

Intervention Hierarchy (Ancestors)

Ethylene Glycols; Glycols; Alcohols; Organic Chemicals

Study Officials

• Jinbo Yue, Dorcter

  Shandong Cancer Hospital and Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Radiation Oncology Department

Study Record Dates

• First Submitted: May 30, 2024
• First Posted: June 5, 2024
• Study Start: June 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)