- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04137666
NRS 2002: Nutritional Screen in Cancer Patients
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.
This descriptive study will serve three aims:
- Register in the cancer patient's electronic medical record their nutritional status at the admission and when the patient is discharged.
- Determine the percentage of malnourished patients or in the risk of malnutrition who are admitted to hospitalization.
- Recognize the number of patients that required specialized nutritional care.
The 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.
Study Overview
Status
Detailed Description
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.
Statistical analysis: Central tendency measures. The results will be presented with tables and graphs.
Two 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Guayas
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Guayaquil, Guayas, Ecuador, 090505
- Instituto Oncológico Nacional Dr. Juan Tanca Marengo
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Participants older than 18-year old that go to the mentioned service
Exclusion Criteria:
- All patients with more than 48 hours of hospital admission
- Pediatric population.
- Patients with edema, non-malignant conditions (family of SOLCA workers) or with oncologic diagnosis not confirmed
- Participants who use a wheelchair or stretcher and those who cannot stand up
The NRS 2002 screening tool will be used to collect data and register the electronic medical record of each patient according to their nutritional status.
The variables to be recorded in an online Excel shared sheet (Google Drive) are weight, height, BMI, age, cancer diagnosis, associated comorbidities.
For weight determination, a scale (mechanical or electronic) in good condition will be used
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Nutritional Status
Time Frame: 60 days
|
Registration in the cancer patients' Clinical Record their nutritional status when they are admitted and when they are discharged
|
60 days
|
Percentage of malnourished patients or at risk of malnourishment
Time Frame: 60 days
|
To know the percentage of malnourished patients or at risk of malnourishment that are admitted for hospitalization
|
60 days
|
Patients who needed specialized nutritional care
Time Frame: 60 days
|
Recognize the number of patients who needed specialized nutritional care
|
60 days
|
Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- Cerezo, L. Diagnóstico del estado nutricional y su impacto en el tratamiento del cáncer. Oncolog. 2005; 28(3): 23-28.
- Gómez C, Rodríguez L, Luengo L, Zamora P, Celaya S, Zarazaga A. et al. Intervención nutricional en el paciente oncológico adulto. Barcelona: Glosa; 2003.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CISOLGYE20190020
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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