NCT04137666

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

October 22, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 24, 2019

Completed
Last Updated

October 24, 2019

Status Verified

October 1, 2019

Enrollment Period

4 months

First QC Date

October 22, 2019

Last Update Submit

October 22, 2019

Conditions

Keywords

Cancer Hospitalized PatientsNutrition DisordersScoring SystemNutrition SurveysNutrition Assessment

Outcome Measures

Primary Outcomes (3)

  • Nutritional Status

    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

    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

    Recognize the number of patients who needed specialized nutritional care

    60 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Participants older than 18-year old that go to the mentioned service

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Oncológico Nacional Dr. Juan Tanca Marengo

Guayaquil, Guayas, 090505, Ecuador

Location

Related Publications (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.

    PMID: 20160725BACKGROUND
  • 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: 19665873BACKGROUND
  • 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: 28199797BACKGROUND
  • 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.

    PMID: 12765673BACKGROUND
  • Cerezo, L. Diagnóstico del estado nutricional y su impacto en el tratamiento del cáncer. Oncolog. 2005; 28(3): 23-28.

    BACKGROUND
  • Gómez C, Rodríguez L, Luengo L, Zamora P, Celaya S, Zarazaga A. et al. Intervención nutricional en el paciente oncológico adulto. Barcelona: Glosa; 2003.

    BACKGROUND
  • 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: 27637832BACKGROUND
  • 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.

    PMID: 19160896BACKGROUND

MeSH Terms

Conditions

MalnutritionDiseaseNutrition DisordersNeoplasms

Condition Hierarchy (Ancestors)

Nutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2019

First Posted

October 24, 2019

Study Start

June 1, 2019

Primary Completion

October 1, 2019

Study Completion

October 1, 2019

Last Updated

October 24, 2019

Record last verified: 2019-10

Locations