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No-Needle naptime: new trick helps toddlers through cancer treatment

NCT ID NCT06443632

Symptom relief Sponsor: Shandong Cancer Hospital and Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a simple, drug-free method called WASPE to help children aged 0-4 years stay still during radiation therapy for cancer. The method uses activities like watching videos, playing, and eating snacks to keep the child awake and calm. 48 children took part, and the goal was to see if this approach could replace the need for sedation medicine. The results could make treatment easier and safer for young patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

48 people

The number who actually took part.

Started

Jun 2024

Finished

Jun 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Up to 4 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

cancer childhood malignant neoplasm neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pediatric cancer

Contacts and locations

Locations

  • Department of Radiation Oncology, Shandong Cancer Hospital and Institute

    Jinan, Shandong, 0531, China

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