Association Between Different Parameters of Nutritional Assessment and Clinical Outcomes in Cancer Patients

April 9, 2017 updated by: Maria Isabel Toulson Davisson Correia, Federal University of Minas Gerais
Malnutrition in oncologic patients has a negative impact on post- surgical recovery, survival and quality of life. The etiology of malnutrition in cancer patients is multifactorial, therefore, the nutritional assessment should be carried out by different parameters. The objective of this study is to investigate the association and prognostic value of five distinct methods of nutritional assessment (molecular, body composition, functional, anthropometric and subjective) in relation to postoperative complications and short-term survival in patients with cancer. Regarding the molecular parameter, mtor signaling pathwayon will be assessed in rectus muscle samples, harvested in the moment of the operation. Body composition was assessed by computed tomography (CT) and bioelectrical impedance test was conducted to evaluate the phase angle. Handgrip strength was used to determine functionality. The percentage of weight loss in relation to usual weight was the anthropometric parameter used. Subjective Global Assessment (SGA) was used to provide the nutritional diagnosis. Postoperative complications were classified according to the Dindo and Clavien classification. Overall time survival was the period between the first assessment of the patients until death or end of follow-up. Chi-square test, t test, Kaplan-Meier method and the Log Rank test and regression analysis will be used (p <0.05).

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil
        • Hospital of Clinics of the University Federal of Minas Gerais
      • Belo horizonte, Minas Gerais, Brazil, 30640100
        • UFMG Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Cancer patients that will be submitted a surgical treatment at University Hospital of University Federal of Minas Gerais.

Description

Inclusion Criteria:

  • Diagnostic cancer confirmed
  • Over 18 years old
  • Accepted the terms of survey

Exclusion Criteria:

  • Tumor synchronic
  • Inflamattory disease
  • Under 18 years old
  • No accepted the terms of survey

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Cancer group 1
Colorectal cancer patients, under 18 years old, no inflammatory disease, weight loss greater 10% habitual body weight, sarcopenic.
Control group
No cancer patients, under 18 years old, no inflammatory disease, no weight loss, no sarcopenic.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative complications
Time Frame: August, 2016
According to the Dindo-Clavien protocol
August, 2016

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival
Time Frame: July, 2016
Follow up using medical records and telephone contacts
July, 2016

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
mtor signaling pathway
Time Frame: December, 2016
mTOR Elisa kits
December, 2016

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Minas Gerais

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2013

Primary Completion (Actual)

March 1, 2017

Study Completion (Anticipated)

May 1, 2017

Study Registration Dates

First Submitted

September 6, 2016

First Submitted That Met QC Criteria

September 9, 2016

First Posted (Estimate)

September 15, 2016

Study Record Updates

Last Update Posted (Actual)

April 11, 2017

Last Update Submitted That Met QC Criteria

April 9, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FUMinas Gerais

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Scientific publications

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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