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

Launched by SHANDONG CANCER HOSPITAL AND INSTITUTE · May 30, 2024

Keywords

ClinConnect Summary

The WASPE Sleep Adjustment trial is studying a new approach to help very young children (ages 0-4) who are undergoing radiation therapy for cancer. In this age group, many children struggle to stay still during treatment, which can be complicated by their young age and development. Instead of using sedatives, which can have health risks, researchers are exploring psychological methods to help these children adjust to the treatment process. This trial is crucial because pediatric tumors are a leading cause of death in children, and finding safer ways to provide care is essential.

To be eligible for this trial, children must be aged 0-4 and diagnosed with specific types of solid tumors, such as Wilms tumor or neuroblastoma. Parents need to be willing to support the sleep training plan, and the child should be in good health overall. Participants can expect to engage in a sleep training program designed to help them cope with the challenges of radiation therapy. It's important for parents to understand that while this study aims to improve treatment experiences, not all children may qualify due to specific medical conditions.

Gender

ALL

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.

Trial Officials