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

Pediatric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06443632
• Other study ID #: SDZLEC2024-077-01
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: October 1, 2025

Study information

• Verified date: June 2024
• Source: Shandong Cancer Hospital and Institute
• Contact: Jinbo Yue, Dorcter
• Phone: 0531-67626442
• Email: jbyue[@]sdfmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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, improve quality of life (assessed via PedsQL™), and reduce parental anxiety (evaluated using SAS), all monitored by optical surface monitoring systems (OSMS).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: October 1, 2025
• Est. primary completion date: October 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 4 Years

Eligibility

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)
• 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.
• 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.

Related Conditions & MeSH terms

• Pediatric Cancer

Intervention

Other:
• Sleep Adjustment
(1) Establishing a sleep schedule with early bedtime and wake-up times; (2) Establishing a consistent bedtime routine based on the child's preferences, such as wearing a sleep sack, providing soothing touch before sleep, offering a pacifier, using white noise, or playing sleep-inducing music; (3) Setting a fixed afternoon radiotherapy time each day and familiarizing the child with the radiotherapy environment beforehand; (4) Engaging the child in stimulating activities like watching videos, playing with toys, snacking, or outdoor activities to keep them awake from morning until 2 PM before radiotherapy; (5) Ensuring the child reaches deep sleep; (6) Completing the radiotherapy plan.

Locations

Country	Name	City	State
China	Department of Radiation Oncology, Shandong Cancer Hospital and Institute	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong Cancer Hospital and Institute

Country where clinical trial is conducted

China, 

References & Publications (14)

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/S1470-2 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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, Perki — View Citation

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: 10.1186/1748-7 — View Citation

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. — View Citation

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. eCollectio — View Citation

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;1 — View Citation

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. — View Citation

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 he — View Citation

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):8 — View Citation

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):20 — View Citation

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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Completion Rate of Radiotherapy	Number of Successful Radiotherapy Completions / Total Number of Radiotherapy Sessions	1 year
Secondary	Quality of Life Score for the Child	Using the Pediatric Quality of Life Inventory (PedsQL), which ranges from 0 to 100, where higher scores indicate better quality of life	6 months
Secondary	Anxiety Score for the Parent	Using the Self-Rating Anxiety Scale (SAS), which ranges from 20 to 80, where higher scores indicate greater anxiety.	6 months