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Pediatric CancerNCT06443632

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

A study testing WASPE Sleep Adjustment Protocol and Chloral Hydrate in people with Pediatric Cancer, run by Shandong Cancer Hospital and Institute at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages Up to 4 years
Conditions the study is for
Pediatric Cancer
What is being tested?
WASPE Sleep Adjustment Protocol and Chloral Hydrate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteChina
Study dates
1 Jun 2024to 1 Jun 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 4 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Department of Radiation Oncology, Shandong Cancer Hospital and Institute

    Jinan, Shandong, 0531

Other trials in China

About this study

Official title: WASPE Sleep Adjustment for Children Aged 0-4 Years Undergoing Radiation Therapy: A Prospective Randomized Controlled Phase II Clinical Trial

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.

Read the detailed description

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).

Being tested
WASPE Sleep Adjustment Protocol, Chloral Hydrate
Keywords
Pediatric cancer, Radiotherapy, Sleep adjustment
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • WASPE Sleep Adjustment ProtocolBehavioural

    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 HydrateDrug

    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.

Study groups in NCT06443632
Study groupRoleWhat they receive
WASPE Sleep Adjustment ProtocolExperimentalParents 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.
Receives: Behavioral: WASPE Sleep Adjustment Protocol
SedationActive comparatorOral 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.
Receives: Drug: Chloral Hydrate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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).

Secondary outcomes (4)

  1. 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.

    Measured: 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).

  2. 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.

    Measured: ≤ 3 days before radiotherapy and ≈ 7 days after completion

  3. Serum growth hormone (GH)

    Serum GH measured by chemiluminescent immunoassay; change from pre-RT to post-RT compared between groups.

    Measured: ≤ 3 days before radiotherapy and ≈ 7 days after completion

  4. Safety (CTCAE v5.0)

    Incidence and severity of AEs/SAEs graded per CTCAE v5.0, plus treatment interruptions and rescue sedation use.

    Measured: During radiotherapy and ≈ 7 days post-RT

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2024
  2. Study start1 Jun 2024
  3. Primary completion1 Jun 2025
  4. Study completion1 Jun 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06443632
Sponsor's protocol ID
SDZLEC2024-077-01
Status last verified
Dec 2025
First submitted
30 May 2024
Last updated
2 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 30614477

  • 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.

    PubMed 36154677

  • 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.

    PubMed 23273995

  • 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.

    PubMed 25889312

  • 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.

    PubMed 30700212

  • 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.

    PubMed 31439084

  • 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.

    PubMed 19293705

  • Briner A, De Roo M, Dayer A, Muller D, Habre W, Vutskits L. Volatile anesthetics rapidly increase dendritic spine density in the rat medial prefrontal cortex during synaptogenesis. Anesthesiology. 2010 Mar;112(3):546-56. doi: 10.1097/ALN.0b013e3181cd7942.

    PubMed 20124985

  • Haeberli S, Grotzer MA, Niggli FK, Landolt MA, Linsenmeier C, Ammann RA, Bodmer N. A psychoeducational intervention reduces the need for anesthesia during radiotherapy for young childhood cancer patients. Radiat Oncol. 2008 Jun 4;3:17. doi: 10.1186/1748-717X-3-17.

    PubMed 18522761

  • 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.

    PubMed 37001762

  • 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.

    PubMed 36494032

  • Lawler G. A review of surface guidance in extracranial stereotactic body radiotherapy (SBRT/SABR) for set-up and intra-fraction motion management. Tech Innov Patient Support Radiat Oncol. 2022 Jan 19;21:23-26. doi: 10.1016/j.tipsro.2022.01.001. eCollection 2022 Mar.

    PubMed 35079644

  • Varni JW, Burwinkle TM, Katz ER, Meeske K, Dickinson P. The PedsQL in pediatric cancer: reliability and validity of the Pediatric Quality of Life Inventory Generic Core Scales, Multidimensional Fatigue Scale, and Cancer Module. Cancer. 2002 Apr 1;94(7):2090-106. doi: 10.1002/cncr.10428.

    PubMed 11932914

  • 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.

    PubMed 32111187

  • Shi P, Jiang W, Xu Z, Li M, Liu P, Lin C, Vennarini S, Yu J, Wang J, Yue J. Sleep Adjustment Strategy for Reducing Sedation Use in Pediatric Radiotherapy Under Surface Optical Monitoring: A Pragmatic Randomized Feasibility Trial. Int J Radiat Oncol Biol Phys. 2026 Jul 29:S0360-3016(26)04061-7. doi: 10.1016/j.ijrobp.2026.07.025. Online ahead of print.

    PubMed 42526653

Questions about this trial

What is this clinical trial studying?

A study testing WASPE Sleep Adjustment Protocol and Chloral Hydrate in people with Pediatric Cancer, run by Shandong Cancer Hospital and Institute at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Per-fraction radiotherapy completion without pharmacologic sedation (WASPE arm) (time frame: 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).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06443632, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.

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