Ignite Creation Date:
2025-12-24 @ 10:36 PM
Ignite Modification Date:
2026-02-25 @ 6:35 PM
Study NCT ID:
NCT01687335
Status:
COMPLETED
Last Update Posted:
2023-03-10
First Post:
2011-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact on the Nutritional State and the Quality of Life
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2016-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-09', 'studyFirstSubmitDate': '2011-10-06', 'studyFirstSubmitQcDate': '2012-09-17', 'lastUpdatePostDateStruct': {'date': '2023-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-09-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "quality of life's improvement", 'timeFrame': '3 YEARS'}, {'measure': 'improvement of treatment effectiveness,', 'timeFrame': '3 YEARS'}, {'measure': 'improvement of their survival', 'timeFrame': '3 YEARS'}], 'secondaryOutcomes': [{'measure': 'improvement of the screening of the undernutrition', 'timeFrame': '3 YEARS'}, {'measure': 'the answer to the treatment', 'timeFrame': '3 years'}, {'measure': 'the estimation of the survival with regard to the nutritional state of the patient.', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['chemotherapy'], 'conditions': ['Cancer']}, 'referencesModule': {'references': [{'pmid': '28449674', 'type': 'DERIVED', 'citation': 'Salas S, Mercier S, Moheng B, Olivet S, Garcia ME, Hamon S, Sibertin-Blanc C, Duffaud F, Auquier P, Baumstarck K. Nutritional status and quality of life of cancer patients needing exclusive chemotherapy: a longitudinal study. Health Qual Life Outcomes. 2017 Apr 27;15(1):85. doi: 10.1186/s12955-017-0660-6.'}]}, 'descriptionModule': {'briefSummary': 'The prevalence of malnutrition in cancerous patients varies between 50% and 80%. It is variable in function: the location and the extension of the tumor, of the general state , of age, of the socio-economic class and the pain. The health consequences of a malnutrition are very important: aggravation of the state of health, complications of treatment, hospitalization, alteration of the quality of life and decrease the survival, and the treatment response.\n\nNutrition being very important in patients, there are recommendations for the nutritional care of these patients, formulated by the European Society for Clinical Nutrition and Metabolism. The investigators do not know to what extent these recommendations are respected in practice and their influence on the nutritional status and the quality of life of patients.\n\nThe investigators therefore propose to assess the conformity of the nutritional care patients in clinical practice in relation to the European recommendations and in a second time to assess the influence of this compliance or non-compliance on the nutritional status clinical and biological of cancerous patients under chemotherapy, on their quality of life, on their response to treatment and on their survival.\n\nThe investigators will try to identify factors that may be linked to the non-compliance such as the characteristics of the cancer disease, socio-demographic characteristics of the subject and the factors related to the structure in which it is supported.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'cancerous patients benefiting from a treatment by chemotherapy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-year-old subject in 85 years in the inclusion\n* Subject presenting a cancerous pathology requiring a systematic treatment by exclusive chemotherapy for a minimal duration of three months with a plan of 3 cures of chemotherapy with an interval between the cures of 21 days\n* Presenting subject one of these 4 cancerous pathologies: cancer of the aéro-digestive ways superiors, sarcomas, colorectal cancers, broncho-lung cancers\n* Subject having the capacity of lira and to understand(include) French\n* Subject having signed lit(enlightened) consent\n* Subject taken care for its cancerous pathology in one of the partner services of the project\n* Subject affiliated to the national insurance scheme\n\nExclusion Criteria:\n\n* Subject having benefited from a major surgical operation in 4 weeks preceding the inclusion\n* Subject having benefited from a radiotherapy in two weeks before the inclusion\n* Subject minor(miner), pregnant woman, subject incapable to give its consent, subject under supervision(guardianship) - guardianship'}, 'identificationModule': {'nctId': 'NCT01687335', 'briefTitle': 'Impact on the Nutritional State and the Quality of Life', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique Hopitaux De Marseille'}, 'officialTitle': 'Conformity With European Recommendations Concerning the Nutritional Care of the Cancerous Patients Benefiting From a Treatment by Chemotherapy Impact on the Nutritional State and the Quality of Life', 'orgStudyIdInfo': {'id': '2011-A00631-40'}, 'secondaryIdInfos': [{'id': '2011-11', 'type': 'OTHER', 'domain': 'AP HM'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'cancerous patients', 'description': 'the patients benefiting from treatment by chemotherapy.', 'interventionNames': ['Other: answering questionnare in differents time of the treatment']}], 'interventions': [{'name': 'answering questionnare in differents time of the treatment', 'type': 'OTHER', 'armGroupLabels': ['cancerous patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13354', 'city': 'Marseille', 'country': 'France', 'facility': 'Assistance Publique Hopitaux de Marseille', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}], 'overallOfficials': [{'name': 'BERNARD BELAIGUES', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assistance Publique hôpitaux de Marseille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique Hopitaux De Marseille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}