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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.
This is a prospective, randomized, open-label, pragmatic feasibility trial comparing a structured behavioral sleep-adjustment protocol (WASPE) with standard pharmacologic sedation to support radiotherapy (RT) delivery in children 0-4 years. Eligible patients have non-head-and-neck solid tumors indicated for external-beam RT and are randomized 2:1 to WASPE or sedation. To focus on children who typically require assistance to complete daily RT, those able to maintain treatment position without assistance are excluded.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Radiotherapy positioning accuracy (CBCT/OSMS) | Interfraction setup error is quantified using pre-treatment CBCT registration to the planning CT along lateral, longitudinal, and vertical axes. Intrafraction motion is assessed using real-time optical surface monitoring system (OSMS) tracking, including total deviation and beam-on deviation metrics. A 5-mm motion threshold is applied; persistent deviations trigger treatment pause, patient repositioning, and CBCT re-verification as clinically indicated. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jinbo Yue, Dorcter | Shandong Cancer Hospital and Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Radiation Oncology, Shandong Cancer Hospital and Institute | Jinan | Shandong | 0531 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30614477 | Result | Bhakta 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. | |
| 36154677 | Result | Ni 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. |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D002697 | Chloral Hydrate |
| ID | Term |
|---|---|
| D005026 | Ethylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| 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. |
|
| 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) | Peripheral blood samples analyzed by ELISA to quantify IgA/IgG/IgM; change from pre-RT to post-RT compared between groups. | ≤ 3 days before radiotherapy and ≈ 7 days after completion |
| Serum growth hormone (GH) | Serum GH measured by chemiluminescent immunoassay; change from pre-RT to post-RT compared between groups. | ≤ 3 days before radiotherapy and ≈ 7 days after completion |
| Safety (CTCAE v5.0) | Incidence and severity of AEs/SAEs graded per CTCAE v5.0, plus treatment interruptions and rescue sedation use. | During radiotherapy and ≈ 7 days post-RT |
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| 19293705 | Result | 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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| 37001762 | Result | 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. |
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| 32111187 | Result | Dunstan DA, Scott N. Norms for Zung's Self-rating Anxiety Scale. BMC Psychiatry. 2020 Feb 28;20(1):90. doi: 10.1186/s12888-019-2427-6. |