Determining Energy Needs in Colorectal Cancer — RECODE  

Colorectal Cancer Clinical Trial

Official title: Resting Energy Expenditure in Cancer - Associations With Body Composition, Dietary Intake, and Exercise Habits

Status Completed

Clinical Trial Summary

This is an observational study to assess the determinants of energy expenditure in cancer, and how those change throughout the disease trajectory. The investigators hypothesize that skeletal muscle will be the primary determinant of energy expenditure throughout the disease trajectory.

Clinical Trial Description

Proper nutrition is a hallmark of successful cancer treatment. Adequate energy intake helps to maintain body weight and composition, improving outcomes such as response to therapy, quality of life, and survival. Unfortunately, little is known about energy needs in cancer, as few studies have assessed energy expenditure (the amount of calories used/day). Furthermore, individuals with cancer often experience muscle loss (sarcopenia), changes in physical activity, and undergo treatment, all of which might substantially alter energy needs. Equations to estimate energy REE (and thus dietary requirements) were created from cohorts of healthy individuals, and no tools that can be easily used in clinical settings are validated to assess REE.

The overarching aim of this study is to evaluate the largest component of energy needs - resting energy expenditure (REE) in relation to body composition (skeletal muscle, adipose tissue) and physical activity in a cohort of patients with colorectal cancer. Other aims will explore the changes in energy expenditure and determine the accuracy of a portable indirect calorimeter for measuring REE.

Newly-diagnosed individuals with stage II-IV colorectal cancer will undergo indirect calorimetry to assess REE. Body composition will be measured by CT scans, with sarcopenia status based on previously published cut-points. Nutritional status and inflammation (C-reactive protein, neutrophil:lymphocyte) will be assessed as confounding variables.

Total energy expenditure will be measured near treatment start in a sub-sample of 20 participants with colorectal cancer using doubly labeled water and accelerometers. Participants will wear accelerometers (ActiCal) for 14 days to provide detailed physical activity data.These assessments will also be preformed in a sub-sample of 20 participants after treatment end.

An additional part of this study will assess the validity of a portable indirect calorimeter for measuring REE. To address this, a sub-group of patients will be invited to undergo an additional test of REE using a portable indirect calorimeter, the FitMate (COSMED). Results will be compared using Pearson's correlation, dependent samples t-test, and Bland-Altman analysis to assess agreement between the FitMate and validated indirect calorimeters (VMax metabolic cart and whole body calorimtery unit). Exploratory outcomes include phase angle by bioelectrical impedance analysis, handgrip strength, calf circumference, and nutrition status by patient generated subjective global assessment (PG-SGA).

The results from this project will provide a basis of better energy recommendations to sustain body weight and composition, thereby improving prognosis in cancer. ;

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

• NCT number: NCT03131921
• Study type: Observational
• Source: University of Alberta
• Status: Completed
• Start date: April 5, 2016
• Completion date: August 18, 2022