NCT06443632Completed
WASPE Sleep Adjustment for Children Aged 0-4 Years Undergoing Radiation Therapy
WASPE Sleep Adjustment for Children Aged 0-4 Years Undergoing Radiation Therapy: A Prospective Randomized Controlled Phase II Clinical Trial
Source: ClinicalTrials.gov · Last updated 2 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 48 (actual)
- First submitted
- 30 May 2024
- Start date
- 1 Jun 2024
- Primary completion date
- 1 Jun 2025
- Lead sponsor
- Shandong Cancer Hospital and Institute
- Diseases
- Childhood cancers
- NCT number
- NCT06443632
What you commit to
- Study type: Interventional
- Participants enrolled: 48
- From 1 Jun 2024 to the primary completion date, 1 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: - to 4 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Radiation Oncology, Shandong Cancer Hospital and Institute Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.