Colorectal CancerRECODENCT03131921
Determining Energy Needs in Colorectal Cancer
An observational study of Colorectal Cancer, run by University of Alberta at 2 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Colorectal Cancer
- Type of treatment
- Injection or infusion
- How many people
- 20 participants
- Where
- 2 sitesCanada
- Study dates
- 5 Apr 2016to 18 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with colorectal cancer (stage II-IV) at the Cross Cancer Institute (Edmonton, Alberta, Canada)
Who may be able to join
- 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
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- 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
Who cannot join
- 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);
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- 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:
- 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
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
University of Alberta
Edmonton, Alberta, T6G2E1
Cross Cancer Institute
Edmonton, Alberta
About this study
Official title: Resting Energy Expenditure in Cancer - Associations With Body Composition, Dietary Intake, and Exercise Habits
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.
Read the 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.
- Conditions
- Colorectal Cancer
- Keywords
- Energy expenditure, Nutrition, Colorectal cancer, Dietary needs
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Colorectal cancer | No intervention. Patients with newly diagnosed stage II-IV colorectal cancer will be enrolled. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resting energy expenditure
To assess resting energy expenditure using indirect calorimtery
Measured: At baseline, before or immediately beginning cancer treatment
Secondary outcomes (2)
Body composition
To assess skeletal muscle and adipose tissue using computerized tomography images taken before beginning cancer treatment
Measured: At baseline, before or immediately beginning cancer treatment
Total energy expenditure
To assess total energy expenditure (one time, over 14 days) using doubly labeled water and accelerometers
Measured: Post-treatment, within 3 years after completion of cancer treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2017
- Study start5 Apr 2016
- Primary completion18 Aug 2022
- Study completion18 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Carla M Prado, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03131921
- Sponsor's protocol ID
- HREBA.CC.15-0204
- Other IDs
- No grant number.
- Acronym
- RECODE
- Status last verified
- Aug 2023
- First submitted
- 24 Apr 2017
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Prado CM, Lieffers JR, McCargar LJ, Reiman T, Sawyer MB, Martin L, Baracos VE. Prevalence and clinical implications of sarcopenic obesity in patients with solid tumours of the respiratory and gastrointestinal tracts: a population-based study. Lancet Oncol. 2008 Jul;9(7):629-35. doi: 10.1016/S1470-2045(08)70153-0. Epub 2008 Jun 6.
PubMed 18539529Purcell SA, Elliott SA, Baracos VE, Chu QS, Prado CM. Key determinants of energy expenditure in cancer and implications for clinical practice. Eur J Clin Nutr. 2016 Nov;70(11):1230-1238. doi: 10.1038/ejcn.2016.96. Epub 2016 Jun 8.
PubMed 27273068Moses AW, Slater C, Preston T, Barber MD, Fearon KC. Reduced total energy expenditure and physical activity in cachectic patients with pancreatic cancer can be modulated by an energy and protein dense oral supplement enriched with n-3 fatty acids. Br J Cancer. 2004 Mar 8;90(5):996-1002. doi: 10.1038/sj.bjc.6601620.
PubMed 14997196Skipworth RJ, Stene GB, Dahele M, Hendry PO, Small AC, Blum D, Kaasa S, Trottenberg P, Radbruch L, Strasser F, Preston T, Fearon KC, Helbostad JL; European Palliative Care Research Collaborative (EPCRC). Patient-focused endpoints in advanced cancer: criterion-based validation of accelerometer-based activity monitoring. Clin Nutr. 2011 Dec;30(6):812-21. doi: 10.1016/j.clnu.2011.05.010. Epub 2011 Jul 5.
PubMed 21733604Reeves MM, Battistutta D, Capra S, Bauer J, Davies PS. Resting energy expenditure in patients with solid tumors undergoing anticancer therapy. Nutrition. 2006 Jun;22(6):609-15. doi: 10.1016/j.nut.2006.03.006.
PubMed 16704954Kyle UG, Soundar EP, Genton L, Pichard C. Can phase angle determined by bioelectrical impedance analysis assess nutritional risk? A comparison between healthy and hospitalized subjects. Clin Nutr. 2012 Dec;31(6):875-81. doi: 10.1016/j.clnu.2012.04.002. Epub 2012 May 4.
PubMed 22560739Purcell SA, Elliott SA, Walter PJ, Preston T, Cai H, Skipworth RJE, Sawyer MB, Prado CM. Total energy expenditure in patients with colorectal cancer: associations with body composition, physical activity, and energy recommendations. Am J Clin Nutr. 2019 Aug 1;110(2):367-376. doi: 10.1093/ajcn/nqz112.
PubMed 31225583
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resting Energy Expenditure in Cancer - Associations With Body Composition, Dietary Intake, and Exercise Habits
- ClinicalTrials.gov ID
- NCT03131921
- Acronym / sponsor ID
- RECODE / HREBA.CC.15-0204
- Conditions
- Colorectal Cancer
- Keywords
- Energy expenditure, Nutrition, Colorectal cancer, Dietary needs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 5 Apr 2016 (actual)
- Primary completion
- 18 Aug 2022 (actual)
- Study completion
- 18 Aug 2022 (actual)
- First posted
- 27 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Colorectal cancer | – | –No intervention. Patients with newly diagnosed stage II-IV colorectal cancer will be enrolled. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with colorectal cancer (stage II-IV) at the Cross Cancer Institute (Edmonton, Alberta, Canada)
Key inclusion criteria (11 listed)
- 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;
Key exclusion criteria (16 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Resting energy expenditure
Time frame: At baseline, before or immediately beginning cancer treatment
To assess resting energy expenditure using indirect calorimtery
2 secondary outcomes
Body composition
Time frame: At baseline, before or immediately beginning cancer treatment
Total energy expenditure
Time frame: Post-treatment, within 3 years after completion of cancer treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
- Background: PubMed 18539529Prado CM, Lieffers JR, McCargar LJ, Reiman T, Sawyer MB, Martin L, Baracos VE. Prevalence and clinical implications of sarcopenic obesity in patients with solid tumours of the respiratory and gastrointestinal tracts: a population-based study. Lancet Oncol. 2008 Jul;9(7):629-35. doi: 10.1016/S1470-2045(08)70153-0. Epub 2008 Jun 6.
- Background: PubMed 27273068Purcell SA, Elliott SA, Baracos VE, Chu QS, Prado CM. Key determinants of energy expenditure in cancer and implications for clinical practice. Eur J Clin Nutr. 2016 Nov;70(11):1230-1238. doi: 10.1038/ejcn.2016.96. Epub 2016 Jun 8.
- Background: PubMed 14997196Moses AW, Slater C, Preston T, Barber MD, Fearon KC. Reduced total energy expenditure and physical activity in cachectic patients with pancreatic cancer can be modulated by an energy and protein dense oral supplement enriched with n-3 fatty acids. Br J Cancer. 2004 Mar 8;90(5):996-1002. doi: 10.1038/sj.bjc.6601620.
- Background: PubMed 21733604Skipworth RJ, Stene GB, Dahele M, Hendry PO, Small AC, Blum D, Kaasa S, Trottenberg P, Radbruch L, Strasser F, Preston T, Fearon KC, Helbostad JL; European Palliative Care Research Collaborative (EPCRC). Patient-focused endpoints in advanced cancer: criterion-based validation of accelerometer-based activity monitoring. Clin Nutr. 2011 Dec;30(6):812-21. doi: 10.1016/j.clnu.2011.05.010. Epub 2011 Jul 5.
- Background: PubMed 16704954Reeves MM, Battistutta D, Capra S, Bauer J, Davies PS. Resting energy expenditure in patients with solid tumors undergoing anticancer therapy. Nutrition. 2006 Jun;22(6):609-15. doi: 10.1016/j.nut.2006.03.006.
- Background: PubMed 22560739Kyle UG, Soundar EP, Genton L, Pichard C. Can phase angle determined by bioelectrical impedance analysis assess nutritional risk? A comparison between healthy and hospitalized subjects. Clin Nutr. 2012 Dec;31(6):875-81. doi: 10.1016/j.clnu.2012.04.002. Epub 2012 May 4.
- Derived from this study: PubMed 31225583Purcell SA, Elliott SA, Walter PJ, Preston T, Cai H, Skipworth RJE, Sawyer MB, Prado CM. Total energy expenditure in patients with colorectal cancer: associations with body composition, physical activity, and energy recommendations. Am J Clin Nutr. 2019 Aug 1;110(2):367-376. doi: 10.1093/ajcn/nqz112.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carla M Prado principal investigator
University of Alberta
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by University of Alberta at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resting energy expenditure (time frame: At baseline, before or immediately beginning cancer treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03131921, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2023.