Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2026-03-10 @ 11:51 PM
Study NCT ID:
NCT03971656
Status:
COMPLETED
Last Update Posted:
2023-09-13
First Post:
2019-05-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preoperative Nutritional Intervention in Head and Neck Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019587', 'term': 'Dietary Supplements'}, {'id': 'D004522', 'term': 'Educational Status'}], 'ancestors': [{'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2022-10-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-11', 'studyFirstSubmitDate': '2019-05-24', 'studyFirstSubmitQcDate': '2019-05-31', 'lastUpdatePostDateStruct': {'date': '2023-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Scored Patient-Generated Subjective Global Assessment', 'timeFrame': 'Baseline and day of surgery', 'description': 'PG-SGA is an interdisciplinary patient assessment of weight, intake, symptoms, functional status, disease state, metabolic stress and nutritional physical examination'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cancer', 'Surgery', 'Malnutrition', 'Preoperative', 'Nutrition'], 'conditions': ['Head and Neck Cancer', 'Malnutrition']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the impact of preoperative nutritional supplements on head and neck surgery patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over the age of 18 who are seen in the Department of Otolaryngology-Head and Neck Surgery clinic, have a new H\\&N cancer diagnosis, and have not undergone previous treatment for H\\&N cancer are eligible for this study. We will enroll only patients who will be undergoing primary surgery for their cancer treatment, and those undergoing primary radiation or primary chemoradiation for treatment will be excluded. All eligible patients will undergo nutritional screening using the PG-SGA. Those who screen positive for malnutrition (\\>1 on the PG-SGA scale) will be randomized to either our standard care (control) versus nutritional intervention group.\n\nExclusion Criteria:\n\n* Prior treatment for head and neck cancer. Those undergoing primary radiation or chemoradiation for their head and neck cancer. Vulnerable populations. Patients who screen as well nourished (\\>1 on the PG-SGA scale) will be excluded as they do not require nutritional intervention. Patients who screen as severely malnourished (\\>8 on the PG-SGA scale) will be excluded as these patients require intervention and should not be potentially randomized to our control arm. Patients requiring nasogastric tube feeding or gastrostomy tube feeding will be excluded. Patients are routinely evaluated by speech pathologist prior to surgery. Those in which there is concern for aspiration will be excluded as they will not be able to participate fully in the intervention.'}, 'identificationModule': {'nctId': 'NCT03971656', 'briefTitle': 'Preoperative Nutritional Intervention in Head and Neck Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Kansas Medical Center'}, 'officialTitle': 'Preoperative Nutritional Intervention in Head and Neck Cancer', 'orgStudyIdInfo': {'id': 'STUDY00143484'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Standard care'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Three-Fold Nutritional Intervention', 'interventionNames': ['Dietary Supplement: Nutritional Supplement', 'Behavioral: Preoperative Dietitian Consult', 'Behavioral: Education']}], 'interventions': [{'name': 'Nutritional Supplement', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Oral nutritional supplementation', 'armGroupLabels': ['Intervention']}, {'name': 'Preoperative Dietitian Consult', 'type': 'BEHAVIORAL', 'description': 'Nutritional assessment', 'armGroupLabels': ['Intervention']}, {'name': 'Education', 'type': 'BEHAVIORAL', 'description': 'Informational materials about nutrition', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Kansas Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}