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Malnutrition (Diagnosis)NCT04137666

NRS 2002: Nutritional Screen in Cancer Patients

An observational study of Malnutrition (Diagnosis) and Nutrition Disorders, run by Sociedad de Lucha Contra el Cáncer del Ecuador at 1 site in Ecuador.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
68 participants
Where
1 siteEcuador
Study dates
1 Jun 2019to 1 Oct 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Ecuador1 site

  • Instituto Oncológico Nacional Dr. Juan Tanca Marengo

    Guayaquil, Guayas, 090505

Other trials in Ecuador

About this study

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:

Read more
  • 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.

Read the 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.

Keywords
Cancer Hospitalized Patients, Nutrition Disorders, Scoring System, Nutrition Surveys, Nutrition Assessment
Medical subject headings
Malnutrition, Disease, Nutrition Disorders, Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Nutritional Status

    Registration in the cancer patients' Clinical Record their nutritional status when they are admitted and when they are discharged

    Measured: 60 days

  2. 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

    Measured: 60 days

  3. Patients who needed specialized nutritional care

    Recognize the number of patients who needed specialized nutritional care

    Measured: 60 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Oct 2019
  2. Study start1 Jun 2019
  3. Primary completion1 Oct 2019
  4. Study completion1 Oct 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04137666
Sponsor's protocol ID
CISOLGYE20190020
Status last verified
Oct 2019
First submitted
22 Oct 2019
Last updated
24 Oct 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 20160725

  • 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.

    PubMed 19665873

  • 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.

    PubMed 28199797

  • 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.

    PubMed 12765673

  • 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.

  • 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.

    PubMed 27637832

  • 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.

    PubMed 19160896

Questions about this trial

What is this clinical trial studying?

An observational study of Malnutrition (Diagnosis) and Nutrition Disorders, run by Sociedad de Lucha Contra el Cáncer del Ecuador at 1 site in Ecuador.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Ecuador. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Nutritional Status (time frame: 60 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04137666, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2019.

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