Clinical trial NCT02901132: Association Between Different Parameters of Nutritional Assessment and Clinical Outcomes in Cancer Patients
Official title: Association Between Different Parameters of Nutritional Assessment and Clinical Outcomes in Cancer Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer
Postoperative Complications
Sarcopenia
Lead sponsor: Federal University of Minas Gerais
Sponsor class: OTHER
First posted: 2016-09-15
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cancer patients that will be submitted a surgical treatment at University Hospital of University Federal of Minas Gerais.

Brief 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).


Eligibility criteria: 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

Primary outcomes:
measure: Postoperative complications
timeFrame: August, 2016
Secondary outcomes:
measure: Survival
timeFrame: July, 2016
Other outcomes:
measure: mtor signaling pathway
timeFrame: December, 2016
Locations:
city: Belo horizonte
country: Brazil
facility: UFMG Hospital
state: Minas Gerais
city: Belo Horizonte
country: Brazil
facility: Hospital of Clinics of the University Federal of Minas Gerais
state: Minas Gerais
Study officials:
References:
citation: Mauricio SF, Xiao J, Prado CM, Gonzalez MC, Correia MITD. Different nutritional assessment tools as predictors of postoperative complications in patients undergoing colorectal cancer resection. Clin Nutr. 2018 Oct;37(5):1505-1511. doi: 10.1016/j.clnu.2017.08.026. Epub 2017 Sep 4.