Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2026-02-20 @ 6:46 AM
Study NCT ID:
NCT02055833
Status:
COMPLETED
Last Update Posted:
2025-05-01
First Post:
2014-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intensive Nutritional Counseling in Head-neck Cancer Patients Undergoing Radiotherapy
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': 'D015596', 'term': 'Nutrition Assessment'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D015991', 'term': 'Epidemiologic Measurements'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 159}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-29', 'studyFirstSubmitDate': '2014-02-04', 'studyFirstSubmitQcDate': '2014-02-04', 'lastUpdatePostDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-02-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Feasibility of radiotherapy', 'timeFrame': '6 weeks', 'description': 'Described as: number of interruptions \\>5 days; total duration (days); dose reduction'}], 'primaryOutcomes': [{'measure': 'Body weight', 'timeFrame': '6 weeks', 'description': 'Change in body weight at the end of radiotherapy (after 6 weeks)'}], 'secondaryOutcomes': [{'measure': 'Body weight', 'timeFrame': '3 months', 'description': 'Change in body weight at 1 month since the end of radiotherapy'}, {'measure': 'Body weight', 'timeFrame': '5 months', 'description': 'Change in body weight at 3 months since the end of radiotherapy'}, {'measure': 'Quality of life', 'timeFrame': '5 months', 'description': 'Trends in quality of life during the study (assessment: at the end of radiotherapy; at 1 month and at 3 months since the end of radiotherapy)'}, {'measure': 'Handgrip strength', 'timeFrame': '5 months', 'description': 'Trends in handgrip strength during the study (assessment: at the end of radiotherapy; at 1 month and at 3 months since the end of radiotherapy)'}, {'measure': 'Phase angle', 'timeFrame': '5 months', 'description': 'Trends in phase angle (as surrogate of body composition) during the study (assessment: at the end of radiotherapy; at 1 month and at 3 months since the end of radiotherapy)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Head-neck Cancer']}, 'referencesModule': {'references': [{'pmid': '23845384', 'type': 'BACKGROUND', 'citation': 'Langius JA, Zandbergen MC, Eerenstein SE, van Tulder MW, Leemans CR, Kramer MH, Weijs PJ. Effect of nutritional interventions on nutritional status, quality of life and mortality in patients with head and neck cancer receiving (chemo)radiotherapy: a systematic review. Clin Nutr. 2013 Oct;32(5):671-8. doi: 10.1016/j.clnu.2013.06.012. Epub 2013 Jun 26.'}, {'pmid': '22345712', 'type': 'BACKGROUND', 'citation': 'Baldwin C, Spiro A, Ahern R, Emery PW. Oral nutritional interventions in malnourished patients with cancer: a systematic review and meta-analysis. J Natl Cancer Inst. 2012 Mar 7;104(5):371-85. doi: 10.1093/jnci/djr556. Epub 2012 Feb 15.'}, {'pmid': '16697500', 'type': 'BACKGROUND', 'citation': 'Arends J, Bodoky G, Bozzetti F, Fearon K, Muscaritoli M, Selga G, van Bokhorst-de van der Schueren MA, von Meyenfeldt M; DGEM (German Society for Nutritional Medicine); Zurcher G, Fietkau R, Aulbert E, Frick B, Holm M, Kneba M, Mestrom HJ, Zander A; ESPEN (European Society for Parenteral and Enteral Nutrition). ESPEN Guidelines on Enteral Nutrition: Non-surgical oncology. Clin Nutr. 2006 Apr;25(2):245-59. doi: 10.1016/j.clnu.2006.01.020. Epub 2006 May 12.'}, {'pmid': '34130709', 'type': 'DERIVED', 'citation': 'Martin B, Cereda E, Caccialanza R, Pedrazzoli P, Tarricone R, Ciani O. Cost-effectiveness analysis of oral nutritional supplements with nutritional counselling in head and neck cancer patients undergoing radiotherapy. Cost Eff Resour Alloc. 2021 Jun 15;19(1):35. doi: 10.1186/s12962-021-00291-7.'}, {'pmid': '29111172', 'type': 'DERIVED', 'citation': 'Cereda E, Cappello S, Colombo S, Klersy C, Imarisio I, Turri A, Caraccia M, Borioli V, Monaco T, Benazzo M, Pedrazzoli P, Corbella F, Caccialanza R. Nutritional counseling with or without systematic use of oral nutritional supplements in head and neck cancer patients undergoing radiotherapy. Radiother Oncol. 2018 Jan;126(1):81-88. doi: 10.1016/j.radonc.2017.10.015. Epub 2017 Oct 27.'}]}, 'descriptionModule': {'briefSummary': 'In head-neck cancer patients undergoing radiotherapy (RT) malnutrition is associated with impaired quality of life, reduced survival, more frequent treatment interruptions and dose reductions. The international guidelines recommend early nutritional support in the presence of nutritional risk, as it allows preventing or treating malnutrition and improving the clinical outcomes, as well as the tolerability of oncologic treatments. Previous nutritional intervention trials in head-neck cancer patients have been conducted on small samples and did not clarify the role of oral nutritional supplements (ONS). Accordingly, although current guidelines recommend as grade A the use of ONS associated with dietary counseling for head-neck cancer patients undergoing RT, the efficacy of this nutritional intervention still needs to be evaluated in adequately sized and randomized clinical trials.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* newly diagnosed head-neck cancer\n* indication to radiotherapy\n* Eastern Cooperative Oncology Group performance status \\<=2\n* availability to planned measurements and to written informed consent.\n\nExclusion Criteria:\n\n* age \\<18 years\n* ongoing artificial nutrition\n* refusal'}, 'identificationModule': {'nctId': 'NCT02055833', 'briefTitle': 'Intensive Nutritional Counseling in Head-neck Cancer Patients Undergoing Radiotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione IRCCS Policlinico San Matteo di Pavia'}, 'officialTitle': 'Intensive Nutritional Counseling in Head-neck Cancer Patients Undergoing Radiotherapy: a Randomized, Controlled Trial', 'orgStudyIdInfo': {'id': '20120001310'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intensive nutritional counseling', 'description': 'Nutritional counseling (follow-up visits once a week for 6 weeks \\[during radiotherapy\\] and at 1 month and at 3 months since the end of radiotherapy) + n-3 polyunsaturated fatty acids-enriched oral nutritional supplements (1-2 bottles/day)', 'interventionNames': ['Dietary Supplement: Intensive nutritional counseling']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Nutritional counseling', 'description': 'Nutritional counseling (follow-up visits once a week for 6 weeks \\[during radiotherapy\\] and at 1 month and at 3 months since the end of radiotherapy)', 'interventionNames': ['Other: Nutritional counseling']}], 'interventions': [{'name': 'Intensive nutritional counseling', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Resource Support Plus (Nestlè Health Science)'], 'description': 'Intensive nutritional counseling: nutritional counseling + oral nutritional supplements', 'armGroupLabels': ['Intensive nutritional counseling']}, {'name': 'Nutritional counseling', 'type': 'OTHER', 'description': 'Nutritional counseling', 'armGroupLabels': ['Nutritional counseling']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27100', 'city': 'Pavia', 'country': 'Italy', 'facility': 'Nutrition and Dietetics Service, Fondazione IRCCS Policlinico San Matteo', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}], 'overallOfficials': [{'name': 'Emanuele Cereda, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nutrition and Dietetics Service, Fondazione IRCCS Policlinico San Matteo'}, {'name': 'Riccardo Caccialanza, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Nutrition and Dietetics Service, Fondazione IRCCS Policlinico San Matteo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione IRCCS Policlinico San Matteo di Pavia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Nestlè Health Science', 'class': 'UNKNOWN'}, {'name': 'Akern Srl', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Emanuele Cereda', 'investigatorAffiliation': 'Fondazione IRCCS Policlinico San Matteo di Pavia'}}}}