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

Shandong First Medical University

Status: Completed

Conditions: Pediatric Cancer

Treatments: Drug: Chloral Hydrate; Behavioral: WASPE Sleep Adjustment Protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT06443632

SDZLEC2024-077-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 patients

Sex: All

Ages: Under 4 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient of any gender, aged 0-4 years
• Pathologically confirmed diagnosis of pediatric malignant solid tumors (including Wilms tumor, neuroblastoma, rhabdomyosarcoma, hepatoblastoma, germ cell tumors, etc.).
• The child's parents can cooperate with the implementation of the sleep training plan.
• Eastern Cooperative Oncology Group (ECOG) performance status score ≤2.
• Expected survival of the patient ≥3 months.
• Normal major organ function (within 14 days before enrollment)
• Growth and immune function are within acceptable ranges as determined by the investigator.
• The patient's parents must provide informed consent for the study before participation and voluntarily sign the informed consent form.

Exclusion criteria

• Primary or metastatic lesions that cannot undergo radiotherapy (as determined by the investigator).
• Children who can independently maintain position fixation.
• Children with clinical signs of central nervous system dysfunction.
• Children with sleep disorders.
• Children with severe growth retardation or immune function impairment.
• Other significant medical conditions that may impact the study (e.g., severe cardiopulmonary diseases). The decision is at the discretion of the investigator.
• Severe or uncontrolled infections.
• Allergy to sedatives.
• The investigator deems the patient unsuitable for participation in this clinical study for other reasons.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

WASPE Sleep Adjustment Protocol

Experimental group

Description:

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.

Treatment:

Behavioral: WASPE Sleep Adjustment Protocol

Sedation

Active Comparator group

Description:

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.

Treatment:

Drug: Chloral Hydrate