Determining Energy Needs in Colorectal Cancer (RECODE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03131921|
Recruitment Status : Recruiting
First Posted : April 27, 2017
Last Update Posted : November 8, 2019
|Condition or disease|
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.
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|Official Title:||Resting Energy Expenditure in Cancer - Associations With Body Composition, Dietary Intake, and Exercise Habits|
|Actual Study Start Date :||April 5, 2016|
|Estimated Primary Completion Date :||July 31, 2020|
|Estimated Study Completion Date :||August 31, 2021|
No intervention. Patients with newly diagnosed stage II-IV colorectal cancer will be enrolled.
- Resting energy expenditure [ Time Frame: At baseline, before or immediately beginning cancer treatment ]To assess resting energy expenditure using indirect calorimtery
- Body composition [ Time Frame: At baseline, before or immediately beginning cancer treatment ]To assess skeletal muscle and adipose tissue using computerized tomography images taken before beginning cancer treatment
- Total energy expenditure [ Time Frame: Post-treatment, within 2 years after completion of cancer treatment ]To assess total energy expenditure (one time, over 14 days) using doubly labeled water and accelerometers
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03131921
|Contact: Claire Trottierfirstname.lastname@example.org|
|University of Alberta||Recruiting|
|Edmonton, Alberta, Canada, T6G2E1|
|Contact: Claire Trottier 7804927820 email@example.com|
|Principal Investigator:||Carla M Prado||University of Alberta|