Ignite Creation Date:
2025-12-24 @ 2:12 PM
Ignite Modification Date:
2026-02-02 @ 4:24 PM
Study NCT ID:
NCT03042195
Status:
COMPLETED
Last Update Posted:
2018-04-10
First Post:
2016-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Supplementary Postoperative Parenteral Nutrition for Head and Neck Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010288', 'term': 'Parenteral Nutrition'}], 'ancestors': [{'id': 'D005248', 'term': 'Feeding Methods'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D018529', 'term': 'Nutritional Support'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-09', 'studyFirstSubmitDate': '2016-12-08', 'studyFirstSubmitQcDate': '2017-02-01', 'lastUpdatePostDateStruct': {'date': '2018-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Biochemical Changes in Liver Parameters; p-alanine aminotransferase, p-bilirubin, alkaline phosphatase and INR (international normalized ratio).', 'timeFrame': 'Baseline and Day 2,3,4'}, {'measure': 'Number of patients who develop coagulopathy defined as increase in INR (international normalized ratio) above the reference level.', 'timeFrame': 'Baseline and Day 2,3,4'}, {'measure': 'Presence of nausea under treatment measured by a VAS-scale (visual analogue scale).', 'timeFrame': 'Day 2,3,4'}, {'measure': 'Presence of oedema measured by weight in kg.', 'timeFrame': 'Day 2,3,4'}, {'measure': 'Causes of insufficient dietary intake, measured by a questionnaire filled out by the patient.', 'timeFrame': 'Day 2,3,4'}, {'measure': 'Presence of vomiting under treatment registered by patient reported cases.', 'timeFrame': 'Day 2,3,4'}], 'primaryOutcomes': [{'measure': 'Postoperative Infectious Complications', 'timeFrame': 'At day 30', 'description': 'Local and systemic'}, {'measure': 'Postoperative Thrombotic Complications', 'timeFrame': 'At day 30'}], 'secondaryOutcomes': [{'measure': 'Fistula formation without infection defined by journal documentation', 'timeFrame': 'Day 1,2,3,4,7,14, 23 and 30', 'description': 'The measurement that will be used is documented fistula formation in the patients´ journal without increased infection parameters (c-reactive protein and leukocytes)'}, {'measure': 'Number of participants who develop Refeeding Syndrome defined as a decrease in p-phosphate and clinical symptoms of refeeding syndrome; edema, dyspnea, hypertension, arrhythmia, confusion and/ or cases of spasm.', 'timeFrame': 'Day 2,3,4', 'description': "Data are collected from the patient's record."}, {'measure': 'Number of participants who develop Refeeding Phenomena defined as a decrease in p-phosphate without clinical symptoms of refeeding syndrome; edema, dyspnea, hypertension, arrhythmia, confusion and/ or cases of spasm.', 'timeFrame': 'Day 2,3,4', 'description': "Data will be collected from the patient's record."}, {'measure': 'Length of stay at the hospital', 'timeFrame': 'Up to 30 days'}, {'measure': 'Coverage of energy requirement, estimated by the Harris Benedict formula. Coverage is estimated by daily dietary registration.', 'timeFrame': 'Day 1,2,3,4'}, {'measure': 'Coverage of protein requirement, estimated in g/kg/day. The coverage is estimated by daily dietary registration.', 'timeFrame': 'Day 1,2,3, 4'}, {'measure': 'Hand Grip Strength measured by a hand grip strength dynamometer in kilograms.', 'timeFrame': 'Baseline and Day 2,3,4'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Supplementary Parenteral Nutrition', 'Postoperative Nutrition', 'Postoperative complications'], 'conditions': ['Head and Neck Neoplasm']}, 'descriptionModule': {'briefSummary': "The purpose of the study is to examine whether postoperative nutrition with endeavours of 100% coverage of the patient's estimated energy and protein needs, can reduce the incidence of postoperative complications."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who completed head and neck cancer surgery and got a feeding tube perioperatively\n* Patients of legal age\n* Patients who can understand and read Scandinavian languages\n\nExclusion Criteria:\n\n* Patients with allergy to components in parenteral nutrition\n* Patients where it is impossible to give parenteral nutrition'}, 'identificationModule': {'nctId': 'NCT03042195', 'acronym': 'SpPN-HNC', 'briefTitle': 'Supplementary Postoperative Parenteral Nutrition for Head and Neck Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Copenhagen'}, 'officialTitle': 'Supplementary Postoperative Parenteral Nutrition for Head and Neck Cancer Patients - A Randomized Trial', 'orgStudyIdInfo': {'id': 'H-16042979'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention group', 'description': 'Supplementary parenteral nutrition', 'interventionNames': ['Other: Parenteral Nutrition']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'The control group will receive standard nutritional care'}], 'interventions': [{'name': 'Parenteral Nutrition', 'type': 'OTHER', 'description': 'Supplementary parenteral nutrition to achieve 100% coverage of estimated needs', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100 Cph OE', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Clinic for Ear, Nose and Throat Surgery, Rigshospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Copenhagen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Jens Rikardt Andersen', 'investigatorAffiliation': 'University of Copenhagen'}}}}