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

• Conditions: Cancer; Postoperative Complications; Sarcopenia

• Registration Number: NCT02901132
• Lead Sponsor: Federal University 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2016-09-06
• Study First Submitted QC: 2016-09-09
• Study First Posted: 2016-09-15
• Primary Completion: 2017-03
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-09
• Last Update Posted: 2017-04-11
• Study Completion: 2017-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postoperative complications	August, 2016	According to the Dindo-Clavien protocol

Secondary Outcome Measures

Name	Time	Method
Survival	July, 2016	Follow up using medical records and telephone contacts

Trial Locations

Locations (2)

Hospital of Clinics of the University Federal of Minas Gerais; 🇧🇷 Belo Horizonte, Minas Gerais, Brazil

UFMG Hospital; 🇧🇷 Belo horizonte, Minas Gerais, Brazil