Overview

This trial is active, not recruiting.

Conditions cancer, postoperative complications, sarcopenia
Sponsor Federal University of Minas Gerais
Start date March 2013
End date July 2016
Trial size 120 participants
Trial identifier NCT02901132, FUMinas Gerais

Summary

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Colorectal cancer patients, under 18 years old, no inflammatory disease, weight loss greater 10% habitual body weight, sarcopenic.
No cancer patients, under 18 years old, no inflammatory disease, no weight loss, no sarcopenic.

Primary Outcomes

Measure
Postoperative complications
time frame: August, 2016

Secondary Outcomes

Measure
Survival
time frame: July, 2016

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Association Between Different Parameters of Nutritional Assessment and Clinical Outcomes in Cancer Patients
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Federal University of Minas Gerais.