Clinical trial NCT06443632: WASPE Sleep Adjustment for Children Aged 0-4 Years Undergoing Radiation Therapy
Official title: WASPE Sleep Adjustment for Children Aged 0-4 Years Undergoing Radiation Therapy: A Prospective Randomized Controlled Phase II Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pediatric Cancer
Keywords: Pediatric cancer
Radiotherapy
Sleep adjustment
Lead sponsor: Shandong Cancer Hospital and Institute
Sponsor class: OTHER
First posted: 2024-06-05
Enrollment: 140
Sex: ALL
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In China, pediatric tumors are the second leading cause of death in children. Radiotherapy is critical to the treatment of pediatric cancer, with about one-third of patients requiring it and nearly 50% for certain cancers, but young age and immature cognitive abilities pose challenges for precise positioning, leading to reliance on sedatives such as propofol or chloral hydrate, which pose health risks. Radiotherapy technicians are exploring new methods such as psychological interventions, but these methods are challenging for children aged 0-4, who account for a high proportion of pediatric cancer cases in China. Therefore, new methods for children aged 0-4 are urgently needed.

Detailed description: Approximately 400,000 children and adolescents globally and 22,000 children in China are diagnosed with malignancies each year, with pediatric tumors being the second leading cause of death in children. Radiotherapy is crucial for pediatric cancer treatment, with about one-third of patients requiring it and nearly 50% for certain cancers, but young age and immature cognitive abilities pose challenges for precise positioning and irradiation, leading to reliance on sedatives like propofol or chloral hydrate, which carry health risks. A retrospective study found a 5.8% incidence of cardiopulmonary complications with propofol-only anesthesia during pediatric radiotherapy, and guidelines and studies indicate that anesthetics pose rare but serious risks and may impact neurological development and learning abilities, highlighting the need to reduce sedative use to minimize side effects and improve long-term quality of life for pediatric cancer patients.

Radiotherapy technicians are exploring new methods like psychological interventions, as shown by Sonja et al.'s study where psychological intervention significantly reduced the need for sedation anesthesia in children undergoing radiotherapy, with better outcomes observed in girls. A 2023 multicenter study found that audiovisual-assisted radiotherapy (AVATAR) effectively reduced sedative use and improved quality of life and anxiety in 3-10-year-old children, with significant QoL improvements for children aged 5-7 and their parents. However, the application of these methods is challenging for children aged 0-4, who account for the highest proportion (30.59%) of newly diagnosed pediatric cancer cases in China. Therefore, new methods for children aged 0-4 years are urgently needed. Our center's prospective study (Oct 2021 - Oct 2022) with 28 children aged 0-4 found that the WASPE method combined with optical surface monitoring systems (OSMS) effectively guided young children to complete radiotherapy with reduced sedative use, with 69% of parents preferring the sleep adjustment method.

Based on promising findings, our study will randomize 0-4-year-old radiotherapy patients into sleep adjustment or conventional sedation groups to compare radiotherapy completion rates, efficiency, accuracy, quality of life (assessed via PedsQL™), immune function indicators and growth hormone levels, and safety.

Eligibility criteria: Inclusion Criteria:

* Patient of any gender, aged 0-4 years
* Pathologically confirmed diagnosis of pediatric malignant solid tumors (including Wilms tumor, neuroblastoma, rhabdomyosarcoma, hepatoblastoma, germ cell tumors, etc.).
* The child's parents can cooperate with the implementation of the sleep training plan.
* Eastern Cooperative Oncology Group (ECOG) performance status score ≤2.
* Expected survival of the patient ≥3 months.
* Normal major organ function (within 14 days before enrollment)
* Growth and immune function are within acceptable ranges as determined by the investigator.
* The patient's parents must provide informed consent for the study before participation and voluntarily sign the informed consent form.

Exclusion Criteria:

* Primary or metastatic lesions that cannot undergo radiotherapy (as determined by the investigator).
* Children who can independently maintain position fixation.
* Children with clinical signs of central nervous system dysfunction.
* Children with sleep disorders.
* Children with severe growth retardation or immune function impairment.
* Other significant medical conditions that may impact the study (e.g., severe cardiopulmonary diseases). The decision is at the discretion of the investigator.
* Severe or uncontrolled infections.
* Allergy to sedatives.
* The investigator deems the patient unsuitable for participation in this clinical study for other reasons.

Primary outcomes:
measure: Completion Rate of Radiotherapy
timeFrame: 1 year
Secondary outcomes:
measure: Quality of Life Score for the Child
timeFrame: 6 months
measure: Radiotherapy efficiency
timeFrame: 6 months
measure: Radiotherapy accuracy
timeFrame: 6 months
measure: Immune function and GH levels
timeFrame: 6 months
measure: Incidence of Adverse Events
timeFrame: 6 months
Other outcomes:
Locations:
city: Jinan
country: China
facility: Department of Radiation Oncology, Shandong Cancer Hospital and Institute
state: Shandong
Study officials:
affiliation: Shandong Cancer Hospital and Institute
name: Jinbo Yue, Dorcter
role: PRINCIPAL_INVESTIGATOR
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