Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2025-12-30 @ 12:50 AM
Study NCT ID:
NCT06443632
Status:
COMPLETED
Last Update Posted:
2025-08-05
First Post:
2024-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
WASPE Sleep Adjustment for Children Aged 0-4 Years Undergoing Radiation Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002697', 'term': 'Chloral Hydrate'}], 'ancestors': [{'id': 'D005026', 'term': 'Ethylene Glycols'}, {'id': 'D006018', 'term': 'Glycols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-31', 'studyFirstSubmitDate': '2024-05-30', 'studyFirstSubmitQcDate': '2024-05-30', 'lastUpdatePostDateStruct': {'date': '2025-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Completion rate of radiotherapy without pharmacological sedation', 'timeFrame': 'Up to 6 weeks', 'description': 'The proportion of patients who complete all planned radiotherapy fractions without requiring pharmacological sedation, assessed by treatment records and parental report.Sessions'}], 'secondaryOutcomes': [{'measure': 'Change in peripheral immune markers (IgA, IgG, IgM)', 'timeFrame': 'Baseline (within 7 days prior to radiotherapy) and Post-RT (within 7 days after completion of up to 28 radiotherapy fractions over 6 weeks)', 'description': 'Peripheral blood samples are collected before and after the radiotherapy course to evaluate changes in immunoglobulin levels.'}, {'measure': 'Positioning accuracy measured by CBCT', 'timeFrame': 'Before each radiotherapy fraction (up to 28 fractions over 6 weeks)', 'description': 'Comparison of daily CBCT images with planning CT to assess pre-treatment positioning error in vertical, longitudinal, and lateral directions.'}, {'measure': 'Intra-fractional motion during radiotherapy (assessed by CBCT and OSMS)', 'timeFrame': 'During each radiotherapy fraction (up to 28 fractions over 6 weeks)', 'description': 'The magnitude of intra-fractional motion is assessed during each radiotherapy fraction using both cone-beam computed tomography (CBCT) and the Optical Surface Monitoring System (OSMS). CBCT is acquired immediately after beam delivery to measure positional deviation in vertical, longitudinal, and lateral directions. OSMS provides continuous real-time tracking of surface motion throughout the treatment.'}, {'measure': 'Change in serum growth hormone (GH) level', 'timeFrame': 'Baseline (within 7 days prior to radiotherapy) and Post-RT (within 7 days after completion of up to 28 radiotherapy fractions over 6 weeks)', 'description': 'Peripheral serum GH levels are measured before and after radiotherapy to assess stress-related endocrine response.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pediatric cancer', 'Radiotherapy', 'Sleep adjustment'], 'conditions': ['Pediatric Cancer']}, 'referencesModule': {'references': [{'pmid': '30614477', 'type': 'RESULT', 'citation': '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/S1470-2045(18)30761-7.'}, {'pmid': '36154677', 'type': 'RESULT', '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 health services among children and adolescents in China: a cross-sectional study. Lancet. 2022 Sep 24;400(10357):1020-1032. doi: 10.1016/S0140-6736(22)01541-0.'}, {'pmid': '23273995', 'type': 'RESULT', '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.'}, {'pmid': '25889312', 'type': 'RESULT', '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.'}, {'pmid': '30700212', 'type': 'RESULT', '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.'}, {'pmid': '31439084', 'type': 'RESULT', '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.'}, {'pmid': '19293705', 'type': 'RESULT', '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):834-48. doi: 10.1097/ALN.0b013e31819c463d.'}, {'pmid': '20124985', 'type': 'RESULT', '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.'}, {'pmid': '18522761', 'type': 'RESULT', '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: 10.1186/1748-717X-3-17.'}, {'pmid': '37001762', 'type': 'RESULT', '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, Perkins SM, Shen CJ, Terezakis S, Bush K, Hiniker SM. Feasibility of the Audio-Visual Assisted Therapeutic Ambience in Radiotherapy (AVATAR) System for Anesthesia Avoidance in Pediatric Patients: A Multicenter Trial. Int J Radiat Oncol Biol Phys. 2023 Sep 1;117(1):96-104. doi: 10.1016/j.ijrobp.2023.03.063. Epub 2023 Mar 30.'}, {'pmid': '36494032', 'type': 'RESULT', '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;13(3):e292-e300. doi: 10.1016/j.prro.2022.11.007. Epub 2022 Dec 6.'}, {'pmid': '35079644', 'type': 'RESULT', '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. eCollection 2022 Mar.'}, {'pmid': '11932914', 'type': 'RESULT', '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):2090-106. doi: 10.1002/cncr.10428.'}, {'pmid': '32111187', 'type': 'RESULT', '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."}]}, 'descriptionModule': {'briefSummary': 'This prospective, randomized controlled Phase II clinical trial aims to evaluate the feasibility and effectiveness of a behavioral sleep adjustment protocol (WASPE: Watching videos, Activities outdoors, Stimulation to stay awake, Playing with toys, Eating snacks) in pediatric patients undergoing radiotherapy. A total of 48 children aged 0-4 years with non-head-and-neck tumors were enrolled and allocated to either the WASPE sleep adjustment group or the sedation group. The primary outcome was the rate of radiotherapy completion without sedation in the WASPE group. Secondary outcomes included motion accuracy (CBCT and OSMS) and physiological biomarkers (IgA, IgG, IgM, GH). This study explores a non-pharmacological alternative to sedation in pediatric radiotherapy preparation.', 'detailedDescription': 'This randomized controlled Phase II trial investigated a non-pharmacological behavioral strategy (WASPE) to assist radiotherapy (RT) delivery in children aged 0-4 years. The WASPE protocol involves Watching videos, engaging in Activities outdoors, Stimulation to stay awake, Playing with toys, and Eating snacks to encourage early wakefulness and natural sleep during RT sessions. Eligible patients were randomly assigned in a 2:1 ratio to the WASPE group or a standard sedation group. Children in the sedation group received oral or rectal chloral hydrate per institutional protocols.\n\nAll patients received image-guided intensity-modulated radiotherapy (IMRT). Pretreatment setup was verified using cone-beam CT (CBCT), and real-time motion was monitored using an optical surface monitoring system (OSMS). A motion threshold of 5 mm was enforced; if deviation exceeded this threshold and did not self-correct, treatment was paused and the patient was repositioned. If motion resolved spontaneously, treatment continued without interruption.\n\nThe primary outcome was the radiotherapy completion rate without sedation in the WASPE group. Secondary outcomes included: (1) inter- and intrafraction motion measured by CBCT and OSMS, and (2) changes in serum biomarkers of immunity (IgA, IgG, IgM) and endocrine function (growth hormone, GH) before and after RT. Although caregiver-requested crossover from the sedation group to the WASPE protocol occurred in some cases, all data were analyzed according to the initial group assignment.\n\nThis study aims to determine whether the WASPE method can serve as a feasible and effective alternative to sedation in very young children undergoing RT, with comparable positioning accuracy and minimal interference with physiological homeostasis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient of any gender, aged 0-4 years\n* Pathologically confirmed diagnosis of pediatric malignant solid tumors (including Wilms tumor, neuroblastoma, rhabdomyosarcoma, hepatoblastoma, germ cell tumors, etc.).\n* The child's parents can cooperate with the implementation of the sleep training plan.\n* Eastern Cooperative Oncology Group (ECOG) performance status score ≤2.\n* Expected survival of the patient ≥3 months.\n* Normal major organ function (within 14 days before enrollment)\n* Growth and immune function are within acceptable ranges as determined by the investigator.\n* The patient's parents must provide informed consent for the study before participation and voluntarily sign the informed consent form.\n\nExclusion Criteria:\n\n* Primary or metastatic lesions that cannot undergo radiotherapy (as determined by the investigator).\n* Children who can independently maintain position fixation.\n* Children with clinical signs of central nervous system dysfunction.\n* Children with sleep disorders.\n* Children with severe growth retardation or immune function impairment.\n* Other significant medical conditions that may impact the study (e.g., severe cardiopulmonary diseases). The decision is at the discretion of the investigator.\n* Severe or uncontrolled infections.\n* Allergy to sedatives.\n* The investigator deems the patient unsuitable for participation in this clinical study for other reasons."}, 'identificationModule': {'nctId': 'NCT06443632', 'briefTitle': 'WASPE Sleep Adjustment for Children Aged 0-4 Years Undergoing Radiation Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Shandong Cancer Hospital and Institute'}, 'officialTitle': 'WASPE Sleep Adjustment for Children Aged 0-4 Years Undergoing Radiation Therapy: A Prospective Randomized Controlled Phase II Clinical Trial', 'orgStudyIdInfo': {'id': 'SDZLEC2024-077-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'WASPE Sleep Adjustment Protocol', 'description': 'Parents are instructed to implement the WASPE protocol (Watching videos, Activities outdoors, Stimulation to stay awake, Playing with toys, and Eating snacks) to keep the child awake from morning until the scheduled RT slot (14:00-16:00), thereby inducing natural deep sleep during RT without pharmacologic sedation. Treatment setup is verified with CBCT and monitored in real time using OSMS with a 5-mm motion threshold.', 'interventionNames': ['Behavioral: WASPE Sleep Adjustment Protocol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sedation', 'description': 'Oral or rectal chloral hydrate (typically 30-50 mg/kg, maximum 1 g) administered approximately 30 minutes before each RT fraction per institutional pediatric sedation protocol. Vital signs are monitored continuously. CBCT and OSMS are used as in the experimental arm.', 'interventionNames': ['Drug: Chloral Hydrate']}], 'interventions': [{'name': 'WASPE Sleep Adjustment Protocol', 'type': 'BEHAVIORAL', 'description': 'Parents are instructed to implement the WASPE protocol (Watching videos, Activities outdoors, Stimulation to stay awake, Playing with toys, and Eating snacks) to keep the child awake from morning until the scheduled RT slot (14:00-16:00), thereby inducing natural deep sleep during RT without pharmacologic sedation. Treatment setup is verified with CBCT and monitored in real time using OSMS with a 5-mm motion threshold.', 'armGroupLabels': ['WASPE Sleep Adjustment Protocol']}, {'name': 'Chloral Hydrate', 'type': 'DRUG', 'description': 'Oral or rectal chloral hydrate (typically 30-50 mg/kg, maximum 1 g) administered approximately 30 minutes before each RT fraction per institutional pediatric sedation protocol. Vital signs are monitored continuously. CBCT and OSMS are used as in the experimental arm.', 'armGroupLabels': ['Sedation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0531', 'city': 'Jinan', 'state': 'Shandong', 'country': 'China', 'facility': 'Department of Radiation Oncology, Shandong Cancer Hospital and Institute', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], 'overallOfficials': [{'name': 'Jinbo Yue, Dorcter', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shandong Cancer Hospital and Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shandong Cancer Hospital and Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Radiation Oncology Department', 'investigatorFullName': 'Jinbo Yue', 'investigatorAffiliation': 'Shandong Cancer Hospital and Institute'}}}}