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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02901132
• Other study ID #: FUMinas Gerais
• Status: Active, not recruiting
• Phase: N/A
• First received: September 6, 2016
• Last updated: April 9, 2017
• Start date: March 2013
• Est. completion date: May 2017

Study information

• Verified date: April 2017
• Source: Federal University of Minas Gerais
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: May 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Postoperative Complications
• Sarcopenia

Locations

Country	Name	City	State
Brazil	Hospital of Clinics of the University Federal of Minas Gerais	Belo Horizonte	Minas Gerais
Brazil	UFMG Hospital	Belo horizonte	Minas Gerais

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Minas Gerais

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	mtor signaling pathway	mTOR Elisa kits	December, 2016
Primary	Postoperative complications	According to the Dindo-Clavien protocol	August, 2016
Secondary	Survival	Follow up using medical records and telephone contacts	July, 2016