Sleep adjustment for young children receiving radiation therapy for cancer
WASPE Sleep Adjustment for Children Aged 0-4 Years Undergoing Radiation Therapy: A Prospective Randomized Controlled Phase II Clinical Trial
This study is testing a new sleep training plan for young children with cancer to see if it can help them feel more comfortable during radiation therapy without needing sedatives.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | N/A to 4 Years |
| Sex | All |
| Sponsor | Shandong Cancer Hospital and Institute Academic / other |
| Locations | 1 site (Jinan, Shandong) |
| Trial ID | NCT06443632 on ClinicalTrials.gov |
What this trial studies
This study focuses on improving the experience of children aged 0-4 years undergoing radiation therapy for pediatric cancer by implementing a sleep adjustment intervention. Given the challenges of positioning young children during treatment, which often leads to the use of sedatives that carry health risks, this approach aims to reduce the reliance on such medications. The study is motivated by the need for safer alternatives that can enhance the quality of life and treatment outcomes for these vulnerable patients. The intervention will involve parents in the implementation of a sleep training plan to help manage their child's anxiety and positioning during therapy.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 0-4 years with a confirmed diagnosis of pediatric malignant solid tumors who can participate in a sleep training plan.
Not a fit: Patients who can independently maintain position fixation or have central nervous system dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce the need for sedatives in young children undergoing radiation therapy, minimizing health risks and improving their overall treatment experience.
How similar studies have performed: Previous studies have shown success with psychological interventions and audiovisual-assisted techniques in reducing sedation needs in similar pediatric populations.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Jinan, Shandong
- Department of Radiation Oncology, Shandong Cancer Hospital and Institute — Jinan, Shandong, China (Recruiting)
Study contacts
- Principal investigator: Jinbo Yue, Dorcter — Shandong Cancer Hospital and Institute
- Study coordinator: Jinbo Yue, Dorcter
- Email: jbyue@sdfmu.edu.cn
- Phone: 0531-67626442
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.