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Determining Energy Needs in Colorectal Cancer (RECODE)

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ClinicalTrials.gov Identifier: NCT03131921
Recruitment Status : Recruiting
First Posted : April 27, 2017
Last Update Posted : June 25, 2020
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Carla Prado, University of Alberta

Study Description
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Brief 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.

Condition or disease
Colorectal Cancer

Detailed 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.

Study Design
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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Colorectal cancer
No intervention. Patients with newly diagnosed stage II-IV colorectal cancer will be enrolled.


Outcome Measures
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Primary Outcome Measures :
  1. Resting energy expenditure [ Time Frame: At baseline, before or immediately beginning cancer treatment ]
    To assess resting energy expenditure using indirect calorimtery


Secondary Outcome Measures :
  1. 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

  2. Total energy expenditure [ Time Frame: Post-treatment, within 3 years after completion of cancer treatment ]
    To assess total energy expenditure (one time, over 14 days) using doubly labeled water and accelerometers


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with colorectal cancer (stage II-IV) at the Cross Cancer Institute (Edmonton, Alberta, Canada)
Criteria

Pre-treatment Participants:

Inclusion Criteria:

  • Recent diagnosis of colorectal cancer (stage II-IV);
  • Able to arrive at the Human Nutrition Research Unit fasted;
  • Patients undergoing treatment should be able to undergo measurements within 20 days of treatment commencement;
  • Able to provide written informed consent;
  • Able to communicate freely in English;
  • Age 18-90

Exclusion Criteria:

  • Recent (within the past month) anti-cancer therapy;
  • Recent invasive surgery (within the last 4 weeks);
  • Women during pregnancy or are breast-feeding;
  • Inability to breathe under the indirect calorimeter hood for 20-30 minutes;
  • Severe toxicity during the 1st cycle therapy (where applicable);
  • Severe mobility issues (e.g. confined to wheelchair);
  • Use of medications that may affect body composition or metabolism will be evaluated individually (e.g. cortico-steroids, hormone replacement, etc.)
  • Patients with a pacemaker

Post-treatment participants:

Inclusion Criteria

  • Recently (<3 year) completed adjuvant chemotherapy treatment for colorectal cancer (stage II-IV)
  • Able to arrive at the Human Nutrition Research Unit fasted
  • Able to provide written informed consent
  • Able to communicate freely in English
  • Age 18-90

Exclusion Criteria

  • Recent (within the past month) anti-cancer therapy
  • Recent invasive surgery (within the last 4 weeks)
  • Women during pregnancy or are breast-feeding
  • Inability to breathe under the indirect calorimeter hood for 20-30 minutes
  • Severe mobility issues (e.g. confined to wheelchair)
  • Use of medications that may affect body composition or metabolism will be evaluated individually (e.g. cortico-steroids, hormone replacement, etc.)
  • Patients with a pacemaker
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Claire Trottier 780-492-7820 ctrottie@ualberta.ca

Locations
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Canada, Alberta
University of Alberta Recruiting
Edmonton, Alberta, Canada, T6G2E1
Contact: Claire Trottier    7804927820    ctrottie@ualberta.ca   
Cross Cancer Institute Recruiting
Edmonton, Alberta, Canada
Contact: Claire Trottier    780-492-7820    ctrottie@ualberta.ca   
Sponsors and Collaborators
University of Alberta
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Carla M Prado University of Alberta
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Carla Prado, Associate Professor, University of Alberta
ClinicalTrials.gov Identifier: NCT03131921    
Other Study ID Numbers: HREBA.CC.15-0204
No grant number. ( Other Identifier: National Institutes of Health )
First Posted: April 27, 2017    Key Record Dates
Last Update Posted: June 25, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Carla Prado, University of Alberta:
Energy expenditure
Nutrition
Colorectal cancer
Dietary needs
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases