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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04137666
Other study ID # CISOLGYE20190020
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2019
Est. completion date October 1, 2019

Study information

Verified date October 2019
Source Sociedad de Lucha Contra el Cáncer del Ecuador
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 68
Est. completion date October 1, 2019
Est. primary completion date October 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Locations

Country Name City State
Ecuador Instituto Oncológico Nacional Dr. Juan Tanca Marengo Guayaquil Guayas

Sponsors (1)

Lead Sponsor Collaborator
Sociedad de Lucha Contra el Cáncer del Ecuador

Country where clinical trial is conducted

Ecuador, 

References & Publications (8)

Arends J, Bachmann P, Baracos V, Barthelemy N, Bertz H, Bozzetti F, Fearon K, Hütterer E, Isenring E, Kaasa S, Krznaric Z, Laird B, Larsson M, Laviano A, Mühlebach 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. — View Citation

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.

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. — View Citation

Marín Caro MM, Gómez Candela C, Castillo Rabaneda R, Lourenço Nogueira T, García Huerta M, Loria Kohen V, Villarino Sanz M, Zamora Auñón P, Luengo Pérez L, Robledo Sáenz P, López-Portabella C, Zarazaga Monzón A, Espinosa Rojas J, Nogués Boqueras R, Rodríguez Suárez L, Celaya Pérez 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. — View Citation

Pressoir M, Desné 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Nutritional Status Registration in the cancer patients' Clinical Record their nutritional status when they are admitted and when they are discharged 60 days
Primary Percentage of malnourished patients or at risk of malnourishment To know the percentage of malnourished patients or at risk of malnourishment that are admitted for hospitalization 60 days
Primary Patients who needed specialized nutritional care Recognize the number of patients who needed specialized nutritional care 60 days
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