NCT02901132

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2013

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

September 6, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 15, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

April 11, 2017

Status Verified

April 1, 2017

Enrollment Period

4 years

First QC Date

September 6, 2016

Last Update Submit

April 9, 2017

Conditions

CancerPostoperative ComplicationsSarcopenia

Outcome Measures

Primary Outcomes (1)

  • Postoperative complications

    According to the Dindo-Clavien protocol

    August, 2016

Secondary Outcomes (1)

  • Survival

    July, 2016

Other Outcomes (1)

  • mtor signaling pathway

    December, 2016

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UFMG Hospital

Belo Horizonte, Minas Gerais, 30640100, Brazil

Location

Hospital of Clinics of the University Federal of Minas Gerais

Belo Horizonte, Minas Gerais, Brazil

Location

Related Publications (1)

  • 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.

    PMID: 28918167DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Samples of abdominal rectal muscles.

MeSH Terms

Conditions

NeoplasmsPostoperative ComplicationsSarcopenia

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalSigns and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PHD

Study Record Dates

First Submitted

September 6, 2016

First Posted

September 15, 2016

Study Start

March 1, 2013

Primary Completion

March 1, 2017

Study Completion

May 1, 2017

Last Updated

April 11, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will share

Scientific publications

Locations

BR(2)