Clinical trial · Interventional
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
NCT06443632CI-TRIAL-00099997completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pediatric Cancer | Childhood Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chloral Hydrate | Drug | — | UNRESOLVED |
| WASPE Sleep Adjustment Protocol | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- WASPE Sleep Adjustment Protocol
- 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.
- interventionNames
- Behavioral: WASPE Sleep Adjustment Protocol
- type
- ACTIVE_COMPARATOR
- label
- Sedation
- 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.
- interventionNames
- Drug: Chloral Hydrate
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 4 Years
Show eligibility criteria text
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.
References
Publications (15)
- RESULTBhakta N, Force LM, Allemani C, Atun R, Bray F, Coleman MP, Steliarova-Foucher E, Frazier AL, Robison LL, Rodriguez-Galindo C, Fitzmaurice C. Childhood cancer burden: a review of global estimates. Lancet Oncol. 2019 Jan;20(1):e42-e53. doi: 10.1016/S1470-2045(18)30761-7. PMID 30614477
- RESULTNi X, Li Z, Li X, Zhang X, Bai G, Liu Y, Zheng R, Zhang Y, Xu X, Liu Y, Jia C, Wang H, Ma X, Zheng H, Su Y, Ge M, Zeng Q, Wang S, Zhao J, Zeng Y, Feng G, Xi Y, Deng Z, Guo Y, Yang Z, Zhang J. Socioeconomic inequalities in cancer incidence and access to health services among children and adolescents in China: a cross-sectional study. Lancet. 2022 Sep 24;400(10357):1020-1032. doi: 10.1016/S0140-6736(22)01541-0. PMID 36154677
- RESULTJairam 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. PMID 23273995
- RESULTMcMullen 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. PMID 25889312
- RESULTYildirim 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. PMID 30700212
- RESULTCote 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. PMID 31439084
- RESULTStratmann 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.