Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2025-12-30 @ 5:13 AM
Study NCT ID:
NCT06730204
Status:
RECRUITING
Last Update Posted:
2024-12-12
First Post:
2024-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Standardized Nutritional Management of Pediatric Patients With Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-11', 'studyFirstSubmitDate': '2024-11-05', 'studyFirstSubmitQcDate': '2024-12-11', 'lastUpdatePostDateStruct': {'date': '2024-12-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'fecal intestinal flora', 'timeFrame': '3 months after enrollment', 'description': 'For children with short peptide type enteral nutrition intervention, the above indicators will be collected at the time of enrollment and 3 months after enrollment.'}, {'measure': 'Endotoxin', 'timeFrame': '3 months after enrollment', 'description': 'For children with short peptide type enteral nutrition intervention, the above indicators will be collected at the time of enrollment and 3 months after enrollment.'}, {'measure': 'Diamine oxidase', 'timeFrame': '3 months after enrollment', 'description': 'For children with short peptide type enteral nutrition intervention, the above indicators will be collected at the time of enrollment and 3 months after enrollment.'}, {'measure': 'D-lactic acid', 'timeFrame': '3 months after enrollment', 'description': 'For children with short peptide type enteral nutrition intervention, the above indicators will be collected at the time of enrollment and 3 months after enrollment.'}], 'primaryOutcomes': [{'measure': 'Weight for age Z score', 'timeFrame': '1, 2, 3, 6, 12, 18, and 24 months after enrollment', 'description': 'Weight for age Z score = (Actual weight - reference population median) / reference population standard deviation'}, {'measure': 'height/length for age Z score', 'timeFrame': '1, 2, 3, 6, 12, 18, and 24 months after enrollment', 'description': 'Height/length for age Z score = (Actual height/length - reference population median) / reference population standard deviation'}, {'measure': 'BMI for age Z score', 'timeFrame': '1, 2, 3, 6, 12, 18, and 24 months after enrollment', 'description': 'BMI for age Z score = (Actual BMI - reference population median) / reference population standard deviation'}], 'secondaryOutcomes': [{'measure': 'dietary intake', 'timeFrame': '1, 2, 3, 6, 12, 18, and 24 months after enrollment', 'description': 'Unit: kcal/d A 24-hour dietary survey record will be conducted on the children to evaluate the quantity, type and energy of the food consumed.'}, {'measure': 'serum albumin', 'timeFrame': '1, 2, 3, 6, 12, 18, and 24 months after enrollment', 'description': 'Unit: g/L This indicator is measured by the biochemical assembly line Remisol in the hospital laboratory department.'}, {'measure': 'serum prealbumin', 'timeFrame': '1, 2, 3, 6, 12, 18, and 24 months after enrollment', 'description': 'Unit: mg/L This indicator is measured by the biochemical assembly line Remisol in the hospital laboratory department.'}, {'measure': 'hemoglobin', 'timeFrame': '1, 2, 3, 6, 12, 18, and 24 months after enrollment', 'description': 'Unit: g/L This indicator is measured by the hemocytometer XS800I in the hospital laboratory department.'}, {'measure': 'electrolytes', 'timeFrame': '1, 2, 3, 6, 12, 18, and 24 months after enrollment', 'description': 'Unit: mmol/L This indicator is measured by the biochemical assembly line Remisol in the hospital laboratory department.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tumor, Solid', 'Children', 'Nutritional Intervention']}, 'referencesModule': {'references': [{'pmid': '25441588', 'type': 'RESULT', 'citation': 'Olveira G, Tapia MJ, Ocon J, Cabrejas-Gomez C, Ballesteros-Pomar MD, Vidal-Casariego A, Arraiza-Irigoyen C, Olivares J, Conde-Garcia MC, Garcia-Manzanares A, Botella-Romero F, Quilez-Toboso RP, Matia P, Rubio MA, Chicharro L, Burgos R, Pujante P, Ferrer M, Zugasti A, Petrina E, Manjon L, Dieguez M, Carrera MJ, Vila-Bundo A, Urgeles JR, Aragon-Valera C, Sanchez-Vilar O, Breton I, Garcia-Peris P, Munoz-Garach A, Marquez E, Del Olmo D, Pereira JL, Tous MC. Hypoglycemia in noncritically ill patients receiving total parenteral nutrition: a multicenter study. (Study group on the problem of hyperglycemia in parenteral nutrition; Nutrition area of the Spanish Society of Endocrinology and Nutrition). Nutrition. 2015 Jan;31(1):58-63. doi: 10.1016/j.nut.2014.04.023. Epub 2014 May 10.'}, {'pmid': '22535923', 'type': 'RESULT', 'citation': 'White JV, Guenter P, Jensen G, Malone A, Schofield M; Academy Malnutrition Work Group; A.S.P.E.N. Malnutrition Task Force; A.S.P.E.N. Board of Directors. Consensus statement: Academy of Nutrition and Dietetics and American Society for Parenteral and Enteral Nutrition: characteristics recommended for the identification and documentation of adult malnutrition (undernutrition). JPEN J Parenter Enteral Nutr. 2012 May;36(3):275-83. doi: 10.1177/0148607112440285.'}, {'pmid': '19682776', 'type': 'RESULT', 'citation': 'Hulst JM, Zwart H, Hop WC, Joosten KF. Dutch national survey to test the STRONGkids nutritional risk screening tool in hospitalized children. Clin Nutr. 2010 Feb;29(1):106-11. doi: 10.1016/j.clnu.2009.07.006. Epub 2009 Aug 13.'}, {'pmid': '34145597', 'type': 'RESULT', 'citation': 'Mohamed Elfadil O, Steien DB, Narasimhan R, Velapati SR, Epp L, Patel I, Patel J, Hurt RT, Mundi MS. Transition to peptide-based diet improved enteral nutrition tolerance and decreased healthcare utilization in pediatric home enteral nutrition. JPEN J Parenter Enteral Nutr. 2022 Mar;46(3):626-634. doi: 10.1002/jpen.2202. Epub 2021 Jul 19.'}, {'pmid': '30896609', 'type': 'RESULT', 'citation': 'Leonard M, Caldari D, Mas E, Lambe C, Comte A, Ley D, Peretti N, Borderon C, Marinier E, Coste ME, Lamireau T, Rubio A, Turquet A, Dubern B, Dabadie A, Gautry J, Kyheng M, Guimber D, Gottrand F. Experience of Using a Semielemental Formula for Home Enteral Nutrition in Children: A Multicenter Cross-sectional Study. J Pediatr Gastroenterol Nutr. 2019 Apr;68(4):585-590. doi: 10.1097/MPG.0000000000002236.'}, {'pmid': '25752883', 'type': 'RESULT', 'citation': 'Brinksma A, Sanderman R, Roodbol PF, Sulkers E, Burgerhof JG, de Bont ES, Tissing WJ. Malnutrition is associated with worse health-related quality of life in children with cancer. Support Care Cancer. 2015 Oct;23(10):3043-52. doi: 10.1007/s00520-015-2674-0. Epub 2015 Mar 10.'}, {'pmid': '25422273', 'type': 'RESULT', 'citation': 'Becker P, Carney LN, Corkins MR, Monczka J, Smith E, Smith SE, Spear BA, White JV; Academy of Nutrition and Dietetics; American Society for Parenteral and Enteral Nutrition. Consensus statement of the Academy of Nutrition and Dietetics/American Society for Parenteral and Enteral Nutrition: indicators recommended for the identification and documentation of pediatric malnutrition (undernutrition). Nutr Clin Pract. 2015 Feb;30(1):147-61. doi: 10.1177/0884533614557642. Epub 2014 Nov 24.'}, {'pmid': '27637832', 'type': 'RESULT', 'citation': 'Arends J, Bachmann P, Baracos V, Barthelemy N, Bertz H, Bozzetti F, Fearon K, Hutterer E, Isenring E, Kaasa S, Krznaric Z, Laird B, Larsson M, Laviano A, Muhlebach S, Muscaritoli M, Oldervoll L, Ravasco P, Solheim T, Strasser F, de van der Schueren M, Preiser JC. ESPEN guidelines on nutrition in cancer patients. Clin Nutr. 2017 Feb;36(1):11-48. doi: 10.1016/j.clnu.2016.07.015. Epub 2016 Aug 6.'}, {'pmid': '34490992', 'type': 'RESULT', 'citation': 'Sasse P, Bergmann A, Afonso W, Ladas EJ, Ferman S. Malnutrition at diagnosis and throughout therapy in pediatric patients with solid tumors: A single-institution study in a developing country. Pediatr Blood Cancer. 2021 Nov;68(11):e29317. doi: 10.1002/pbc.29317. Epub 2021 Sep 7.'}, {'pmid': '35040171', 'type': 'RESULT', 'citation': 'Runco DV, Stanek JR, Yeager ND, Belsky JA. Malnutrition identification and management variability: An administrative database study of children with solid tumors. JPEN J Parenter Enteral Nutr. 2022 Sep;46(7):1559-1567. doi: 10.1002/jpen.2329. Epub 2022 Feb 10.'}, {'pmid': '33320857', 'type': 'RESULT', 'citation': 'Viana ECRM, Oliveira IDS, Rechinelli AB, Marques IL, Souza VF, Spexoto MCB, Pereira TSS, Guandalini VR. Malnutrition and nutrition impact symptoms (NIS) in surgical patients with cancer. PLoS One. 2020 Dec 15;15(12):e0241305. doi: 10.1371/journal.pone.0241305. eCollection 2020.'}, {'pmid': '32366995', 'type': 'RESULT', 'citation': 'Bullock AF, Greenley SL, McKenzie GAG, Paton LW, Johnson MJ. Relationship between markers of malnutrition and clinical outcomes in older adults with cancer: systematic review, narrative synthesis and meta-analysis. Eur J Clin Nutr. 2020 Nov;74(11):1519-1535. doi: 10.1038/s41430-020-0629-0. Epub 2020 May 4.'}, {'pmid': '26853397', 'type': 'RESULT', 'citation': 'Schoeman J. Nutritional assessment and intervention in a pediatric oncology unit. Indian J Cancer. 2015 Apr-Jun;52(2):186-90. doi: 10.4103/0019-509X.175832.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to establish a standardized nutrition intervention procedure for children with solid tumors, and to explore the effectiveness and clinical applicability of standardized nutrition management and short peptide-based enteral nutrition intervention for improving the nutritional status of children with malignant solid tumors.\n\nAfter admission, patients in the intervention group will receive standardized nutrition management provided by a nutrition support team composed of dietitians, nutritionists, clinicians, and nursing teams. Basic information, including diet, enteral and parenteral nutrition, nutritional status and clinical data, will be collected during the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '1. Male and female, age 0-18 years old\n2. Pathological diagnosis is malignant solid tumor with untreated initial onset'}, 'identificationModule': {'nctId': 'NCT06730204', 'briefTitle': 'Standardized Nutritional Management of Pediatric Patients With Solid Tumors', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital of Fudan University"}, 'officialTitle': 'Nutrition Strategies and Malnutrition Assessment Management Systems for Preventing Malnutrition in Children With Solid Tumors: an Exploratory Intervention Study', 'orgStudyIdInfo': {'id': '(2023)136'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Standardized nutrition management（+ short peptide ONS) Group', 'description': 'The children in this group will be given standardized nutrition management after admission. They will follow the five-step treatment principle of malnutrition. Diet + nutrition education is the basic way, which is successively promoted to diet + oral nutrition supplement, enteral nutrition, partial enteral nutrition + supplementary parenteral nutrition, and total parenteral nutrition. When a nutritional treatment does not meet 60% of the target energy requirements for 3 to 5 days, the upper step of the treatment can be selected. For infants or newborns, when 75-80% of the target amount cannot be reached for 3-5 days, the upper step of the treatment can be selected.\n\nDuring the study period, an additional 3 months of short peptide oral nutritional supplements (ONS) is expected to be performed in children enrolled from December 1, 2024 to February 28, 2025 to explore the improvement of the nutritional status of the children.', 'interventionNames': ['Dietary Supplement: Standardized nutritional management', 'Dietary Supplement: Standardized nutritional management + short peptide ONS']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Clinical variables, biochemical markers, dietary data, and physical activity data will be collected at baseline and at each visit (admission to hospital, 1, 2, 3, 6, 12, 18, and 24 months after diagnosis).'}], 'interventions': [{'name': 'Standardized nutritional management', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The children will follow the five-step treatment principle of malnutrition. Diet + nutrition education is the basic way, which is successively promoted to diet + oral nutrition supplement, enteral nutrition, partial enteral nutrition + supplementary parenteral nutrition, and total parenteral nutrition. When a nutritional treatment does not meet 60% of the target energy requirements for 3 to 5 days, the upper step of the treatment can be selected. For infants or newborns, when 75-80% of the target amount cannot be reached for 3-5 days, the upper step of the treatment can be selected.', 'armGroupLabels': ['Standardized nutrition management（+ short peptide ONS) Group']}, {'name': 'Standardized nutritional management + short peptide ONS', 'type': 'DIETARY_SUPPLEMENT', 'description': 'During the study period, an additional 3 months of short peptide ONS enteral nutrition intervention is expected to be performed in children enrolled from Dec 1, 2024 to Feb 28, 2025 to explore the improvement of the nutritional status of the children. Short peptide type ONS 30ml/(kg.d) will be taken orally for children under 3 years old, and 20ml/(kg.d) for children over 3 years old. Due to conditional restrictions, standardized nutritional management + short peptide ONS intervention is only carried out in this subgroup.\n\nInclusion criteria for short peptide ONS enteral nutrition intervention:\n\n1. Male and female, age 1-10 years old\n2. Pathological diagnosis is malignant solid tumor with untreated initial onset\n3. It is expected to receive enteral nutrition intervention for 3 months\n4. Clear consciousness, willing to cooperate, no serious dysfunction of major organ functions', 'armGroupLabels': ['Standardized nutrition management（+ short peptide ONS) Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '201102', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Tian Qian, PhD', 'role': 'CONTACT', 'email': 'drqiantian@fudan.edu.cn', 'phone': '021-64931913'}], 'facility': "Children's Hospital of Fudan University", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Tian Qian, PhD', 'role': 'CONTACT', 'email': 'drqiantian@fudan.edu.cn', 'phone': '021-64931913'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital of Fudan University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}