Ignite Creation Date:
2025-12-24 @ 4:42 PM
Ignite Modification Date:
2025-12-30 @ 6:25 AM
Study NCT ID:
NCT04137666
Status:
COMPLETED
Last Update Posted:
2019-10-24
First Post:
2019-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
NRS 2002: Nutritional Screen in Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D004194', 'term': 'Disease'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-22', 'studyFirstSubmitDate': '2019-10-22', 'studyFirstSubmitQcDate': '2019-10-22', 'lastUpdatePostDateStruct': {'date': '2019-10-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Nutritional Status', 'timeFrame': '60 days', 'description': "Registration in the cancer patients' Clinical Record their nutritional status when they are admitted and when they are discharged"}, {'measure': 'Percentage of malnourished patients or at risk of malnourishment', 'timeFrame': '60 days', 'description': 'To know the percentage of malnourished patients or at risk of malnourishment that are admitted for hospitalization'}, {'measure': 'Patients who needed specialized nutritional care', 'timeFrame': '60 days', 'description': 'Recognize the number of patients who needed specialized nutritional care'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cancer Hospitalized Patients', 'Nutrition Disorders', 'Scoring System', 'Nutrition Surveys', 'Nutrition Assessment'], 'conditions': ['Malnutrition (Diagnosis)', 'Nutrition Disorders', 'Nutrition Surveys', 'Scoring System', 'Cancer', 'Nutrition Related Cancer']}, 'referencesModule': {'references': [{'pmid': '20160725', 'type': 'BACKGROUND', 'citation': 'Pressoir M, Desne S, Berchery D, Rossignol G, Poiree B, Meslier M, Traversier S, Vittot M, Simon M, Gekiere JP, Meuric J, Serot F, Falewee MN, Rodrigues I, Senesse P, Vasson MP, Chelle F, Maget B, Antoun S, Bachmann P. Prevalence, risk factors and clinical implications of malnutrition in French Comprehensive Cancer Centres. Br J Cancer. 2010 Mar 16;102(6):966-71. doi: 10.1038/sj.bjc.6605578. Epub 2010 Feb 16.'}, {'pmid': '19665873', 'type': 'BACKGROUND', 'citation': 'Wie GA, Cho YA, Kim SY, Kim SM, Bae JM, Joung H. Prevalence and risk factors of malnutrition among cancer patients according to tumor location and stage in the National Cancer Center in Korea. Nutrition. 2010 Mar;26(3):263-8. doi: 10.1016/j.nut.2009.04.013. Epub 2009 Aug 8.'}, {'pmid': '28199797', 'type': 'BACKGROUND', 'citation': 'Rabito EI, Marcadenti A, da Silva Fink J, Figueira L, Silva FM. Nutritional Risk Screening 2002, Short Nutritional Assessment Questionnaire, Malnutrition Screening Tool, and Malnutrition Universal Screening Tool Are Good Predictors of Nutrition Risk in an Emergency Service. Nutr Clin Pract. 2017 Aug;32(4):526-532. doi: 10.1177/0884533617692527. Epub 2017 Feb 15.'}, {'pmid': '12765673', 'type': 'BACKGROUND', 'citation': 'Kondrup J, Rasmussen HH, Hamberg O, Stanga Z; Ad Hoc ESPEN Working Group. Nutritional risk screening (NRS 2002): a new method based on an analysis of controlled clinical trials. Clin Nutr. 2003 Jun;22(3):321-36. doi: 10.1016/s0261-5614(02)00214-5.'}, {'type': 'BACKGROUND', 'citation': 'Cerezo, L. Diagnóstico del estado nutricional y su impacto en el tratamiento del cáncer. Oncolog. 2005; 28(3): 23-28.'}, {'type': 'BACKGROUND', 'citation': 'Gómez C, Rodríguez L, Luengo L, Zamora P, Celaya S, Zarazaga A. et al. Intervención nutricional en el paciente oncológico adulto. Barcelona: Glosa; 2003.'}, {'pmid': '27637832', 'type': 'BACKGROUND', 'citation': 'Arends J, Bachmann P, Baracos V, Barthelemy N, Bertz H, Bozzetti F, Fearon K, Hutterer E, Isenring E, Kaasa S, Krznaric Z, Laird B, Larsson M, Laviano A, Muhlebach S, Muscaritoli M, Oldervoll L, Ravasco P, Solheim T, Strasser F, de van der Schueren M, Preiser JC. ESPEN guidelines on nutrition in cancer patients. Clin Nutr. 2017 Feb;36(1):11-48. doi: 10.1016/j.clnu.2016.07.015. Epub 2016 Aug 6.'}, {'pmid': '19160896', 'type': 'BACKGROUND', 'citation': 'Marin Caro MM, Gomez Candela C, Castillo Rabaneda R, Lourenco Nogueira T, Garcia Huerta M, Loria Kohen V, Villarino Sanz M, Zamora Aunon P, Luengo Perez L, Robledo Saenz P, Lopez-Portabella C, Zarazaga Monzon A, Espinosa Rojas J, Nogues Boqueras R, Rodriguez Suarez L, Celaya Perez S, Pardo Masferrer J. [Nutritional risk evaluation and establishment of nutritional support in oncology patients according to the protocol of the Spanish Nutrition and Cancer Group]. Nutr Hosp. 2008 Sep-Oct;23(5):458-68. Spanish.'}]}, 'descriptionModule': {'briefSummary': "Diagnosing the nutritional status of cancer patients is extremely important. An appropriate nutritional status supports a better tolerance to the treatment. A working protocol is essential to start with Nutritional Screening. If it is detected Malnutrition Risk or Malnutrition, diet counseling, and the specific therapeutic for each patient must be provided.\n\nThis descriptive study will serve three aims:\n\n* Register in the cancer patient's electronic medical record their nutritional status at the admission and when the patient is discharged.\n* Determine the percentage of malnourished patients or in the risk of malnutrition who are admitted to hospitalization.\n* Recognize the number of patients that required specialized nutritional care.\n\nThe purpose of this study is to determine if 30% of the patients admitted to the headquarters of SOLCA in Guayaquil from the Ecuadorian Cancer Society are at malnutrition risk or with any specific malnutrition level.", 'detailedDescription': 'A prospective, descriptive, non-interventional study that will be performed from July 1st to October 4th of 2019 in all hospitalized patients of the Internal Medicine Service from SOLCA in Guayaquil from the Ecuadorian Cancer Society.\n\nStatistical analysis: Central tendency measures. The results will be presented with tables and graphs.\n\nTwo weeks before the start of the study, the training of the personnel that will intervene in the screening of the participants will be carried out and will have a flow chart of actions to follow according to the status of patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants older than 18-year old that go to the Internal Medicine Service from SOLCA in Guayaquil from the Ecuadorian Cancer Society, from July 1st to October 4th of 2019 in all hospitalized patients of', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants older than 18-year old that go to the mentioned service\n\nExclusion Criteria:\n\n* All patients with more than 48 hours of hospital admission\n* Pediatric population.\n* Patients with edema, non-malignant conditions (family of SOLCA workers) or with oncologic diagnosis not confirmed\n* Participants who use a wheelchair or stretcher and those who cannot stand up\n\nThe NRS 2002 screening tool will be used to collect data and register the electronic medical record of each patient according to their nutritional status.\n\nThe variables to be recorded in an online Excel shared sheet (Google Drive) are weight, height, BMI, age, cancer diagnosis, associated comorbidities.\n\nFor weight determination, a scale (mechanical or electronic) in good condition will be used'}, 'identificationModule': {'nctId': 'NCT04137666', 'briefTitle': 'NRS 2002: Nutritional Screen in Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Sociedad de Lucha Contra el Cáncer del Ecuador'}, 'officialTitle': 'NRS 2002: Nutritional Screen in Cancer Patients', 'orgStudyIdInfo': {'id': 'CISOLGYE20190020'}}, 'contactsLocationsModule': {'locations': [{'zip': '090505', 'city': 'Guayaquil', 'state': 'Guayas', 'country': 'Ecuador', 'facility': 'Instituto Oncológico Nacional Dr. Juan Tanca Marengo', 'geoPoint': {'lat': -2.19616, 'lon': -79.88621}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sociedad de Lucha Contra el Cáncer del Ecuador', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}