Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2026-04-24 @ 2:45 AM
Study NCT ID:
NCT03114202
Status:
UNKNOWN
Last Update Posted:
2017-07-19
First Post:
2017-03-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Nutritional Counseling on Nutritional Status and Quality of Life of 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'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-04-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2018-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-07-14', 'studyFirstSubmitDate': '2017-03-23', 'studyFirstSubmitQcDate': '2017-04-10', 'lastUpdatePostDateStruct': {'date': '2017-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in weight', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Defined as mean weight change'}, {'measure': 'Change in nutritional status', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Defined as mean body mass index change'}, {'measure': 'Change in quality of life', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Self reported quality of life assessed using two questionnaires - Functional Assessment of Cancer Therapy - Head and Neck (FACT-H \\& N) and European Organization for Research and Treatment of Cancer - Quality of life questionnaire - Head and Neck (EORTC-QLQ-H \\& N35).'}], 'secondaryOutcomes': [{'measure': 'Change in patient generated subjective global assessment', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Self reported nutritional assessment by the Scored Patient-Generated Subjective Global Assessment (PG-SGA)'}, {'measure': 'Energy and protein intake', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Mean changes in energy and protein intake, assessed by the 24 hour recording'}, {'measure': 'Fat free mass', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Mean changes in fat free mass, assessed by foot-to-foot bioimpedance'}, {'measure': 'Occurrence of complications due to radiotherapy', 'timeFrame': '12 weeks', 'description': 'Number of patients with complications due to radiotherapy, assessed from medical record'}, {'measure': 'Occurrence of unplanned hospitalization', 'timeFrame': '12 weeks', 'description': 'Number of patients with unplanned hospitalization, assessed from medical record'}, {'measure': 'Occurrence of interruption or delay in treatment.', 'timeFrame': '12 weeks', 'description': 'Number of patients with interruption or delay in treatment, assessed from medical records'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Head and Neck Neoplasms']}, 'descriptionModule': {'briefSummary': 'This study investigates the effects of nutritional counseling versus standard nutritional care on nutritional status and quality of life in patients with head and neck cancer submitted to radiotherapy.Half participants will receive intensive nutritional counseling while the other half will receive standard care.', 'detailedDescription': 'Considering that head and neck cancer patients usually present reduced food intake with consequent involuntary weight loss and significant worsening of quality of life, this study investigates the effects of nutritional counseling versus standard nutritional care on nutritional status and quality of life in patients with head and neck cancer submitted to radiotherapy.\n\nHalf participants (45) will receive intensive nutritional counseling, that is, once they are admitted to the study and once a week during radiotherapy, following the protocol of nutritional care to cancer patients in radiotherapy proposed by the American Dietetic Association (ADA).\n\nThe other half (45) will receive standard care, that is, nutritional counseling / education performed by hospital nurses and nutritional care performed by the hospital nutritionist (when there is a demand, usually 1 to 2 times during oncologic treatment).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with head and neck cancer (oral cavity, oropharynx, hypopharynx and larynx); both sexes; aged 18 years and over, submitted to radiotherapy after chemotherapy or radiotherapy as a first-choice treatment or as adjuvant treatment (post-surgical).\n\nExclusion Criteria:\n\n* Patients using parenteral nutrition; without cognitive ability to understand the concepts of the questionnaires; in palliative radiotherapy.'}, 'identificationModule': {'nctId': 'NCT03114202', 'briefTitle': 'Effects of Nutritional Counseling on Nutritional Status and Quality of Life of Head and Neck Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo General Hospital'}, 'officialTitle': 'Effects of Intensive Nutritional Counseling on Nutritional Status and Quality of Life of Patients With Head and Neck Cancer Undergoing Radiation Therapy', 'orgStudyIdInfo': {'id': '1.954.066'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'Intensive nutritional counseling: once they are admitted to the study and once a week during radiotherapy', 'interventionNames': ['Other: intensive nutritional counseling']}, {'type': 'OTHER', 'label': 'Control group', 'description': 'Standard care: when there is demand, usually 1 to 2 times during radiotherapy', 'interventionNames': ['Other: Standard care']}], 'interventions': [{'name': 'intensive nutritional counseling', 'type': 'OTHER', 'description': 'Individualised nutrition intervention in the form of regular and intensive nutrition counselling by a dietitian, following a predetermined standard nutrition protocol, the Medical Nutrition Therapy (Cancer/Radiation Oncology) protocol of the American Dietetic Association (ADA) every week during radiotherapy. Individually tailored sample meal plans, recipe suggestions and hints to minimise the side effects of the tumour and therapy will be provided.', 'armGroupLabels': ['Intervention group']}, {'name': 'Standard care', 'type': 'OTHER', 'description': 'Nutritional counseling / education performed by hospital nurses and nutritional care performed by the hospital nutritionist.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37130-081', 'city': 'Alfenas', 'state': 'Minas Gerais', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Sheilla Faria', 'role': 'CONTACT', 'email': 'shefaria@hotmail.com', 'phone': '+55(35)37019745'}, {'name': 'Sheilla Faria', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centro de Oncologia da Santa Casa Nossa Senhora do Perpétuo Socorro', 'geoPoint': {'lat': -21.42917, 'lon': -45.94722}}, {'zip': '37014-460', 'city': 'Varginha', 'state': 'Minas Gerais', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Sheilla Faria', 'role': 'CONTACT', 'email': 'shefaria@hotmail.com', 'phone': '+55(35)37019745'}, {'name': 'Sheilla Faria', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fundação Hospitalar do Município de Varginha - Hospital Bom Pastor', 'geoPoint': {'lat': -21.55139, 'lon': -45.43028}}], 'centralContacts': [{'name': 'Jose Eluf Neto', 'role': 'CONTACT', 'email': 'jose.eluf@hc.fm.usp.br', 'phone': '+55(11)3061-8278'}, {'name': 'Sheilla Faria', 'role': 'CONTACT', 'email': 'shefaria@hotmail.com', 'phone': '+55(35)3701-9745'}], 'overallOfficials': [{'name': 'Jose Eluf Neto', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'São Paulo University'}, {'name': 'Andre Carvalho', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital de Cancer de Barretos - Fundação PIO XII'}, {'name': 'Sheilla Faria', 'role': 'STUDY_CHAIR', 'affiliation': 'São Paulo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}