WASPE Sleep Adjustment for Children Aged 0-4 Years Undergoing Radiation Therapy
NCT ID: NCT06443632
Last Updated: 2026-01-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
48 participants
INTERVENTIONAL
2024-06-01
2025-06-01
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
4 Years
ALL
No
Sponsors
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Shandong Cancer Hospital and Institute
OTHER
Responsible Party
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Jinbo Yue
Director of Radiation Oncology Department
Principal Investigators
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Jinbo Yue, Dorcter
Role: PRINCIPAL_INVESTIGATOR
Shandong Cancer Hospital and Institute
Locations
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Department of Radiation Oncology, Shandong Cancer Hospital and Institute
Jinan, Shandong, China
Countries
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References
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Jairam V, Roberts KB, Yu JB. Historical trends in the use of radiation therapy for pediatric cancers: 1973-2008. Int J Radiat Oncol Biol Phys. 2013 Mar 1;85(3):e151-5. doi: 10.1016/j.ijrobp.2012.10.007. Epub 2012 Dec 27.
McMullen KP, Hanson T, Bratton J, Johnstone PA. Parameters of anesthesia/sedation in children receiving radiotherapy. Radiat Oncol. 2015 Mar 11;10:65. doi: 10.1186/s13014-015-0363-2.
Yildirim I, I Celik A, B Bay S, Pasin O, Tutuncu AC. Propofol-based balanced anesthesia is safer in pediatric radiotherapy. J Oncol Pharm Pract. 2019 Dec;25(8):1891-1896. doi: 10.1177/1078155218825296. Epub 2019 Jan 30.
Cote CJ, Wilson S. Guidelines for Monitoring and Management of Pediatric Patients Before, During, and After Sedation for Diagnostic and Therapeutic Procedures. Pediatr Dent. 2019 Jul 15;41(4):259-260.
Stratmann G, Sall JW, May LD, Bell JS, Magnusson KR, Rau V, Visrodia KH, Alvi RS, Ku B, Lee MT, Dai R. Isoflurane differentially affects neurogenesis and long-term neurocognitive function in 60-day-old and 7-day-old rats. Anesthesiology. 2009 Apr;110(4):834-48. doi: 10.1097/ALN.0b013e31819c463d.
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Gutkin PM, Skinner L, Jiang A, Donaldson SS, Loo BW Jr, Oh J, Wang YP, von Eyben R, Snyder J, Bredfeldt JS, Breneman JC, Constine LS, Faught AM, Haas-Kogan D, Holmes JA, Krasin M, Larkin C, Marcus KJ, Maxim PG, McClelland S 3rd, Murphy B, Palmer JD, Perkins SM, Shen CJ, Terezakis S, Bush K, Hiniker SM. Feasibility of the Audio-Visual Assisted Therapeutic Ambience in Radiotherapy (AVATAR) System for Anesthesia Avoidance in Pediatric Patients: A Multicenter Trial. Int J Radiat Oncol Biol Phys. 2023 Sep 1;117(1):96-104. doi: 10.1016/j.ijrobp.2023.03.063. Epub 2023 Mar 30.
Liu P, Huang Q, Zhang T, Zhang X, Shi P, Qi L, Yue J. WASPE Sleep Deprivation, Paired with an Optical Surface Monitoring System, Can Provide Accurate Radiation Therapy to Pediatric Patients Without the Need for Sedation. Pract Radiat Oncol. 2023 May-Jun;13(3):e292-e300. doi: 10.1016/j.prro.2022.11.007. Epub 2022 Dec 6.
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Other Identifiers
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SDZLEC2024-077-01
Identifier Type: -
Identifier Source: org_study_id
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