Determining Energy Needs in Colorectal Cancer

NCT03131921 | Completed

• 2 other identifiers: HREBA.CC.15-0204No grant number.
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Colorectal Cancer

Keywords

Energy expenditure; Nutrition; Colorectal cancer; Dietary needs

Outcome Measures

Primary Outcomes (1)

• Resting energy expenditure

  To assess resting energy expenditure using indirect calorimtery

  At baseline, before or immediately beginning cancer treatment

Secondary Outcomes (2)

• Body composition

  At baseline, before or immediately beginning cancer treatment

• Total energy expenditure

  Post-treatment, within 3 years after completion of cancer treatment

Study Arms (1)

Colorectal cancer

No intervention. Patients with newly diagnosed stage II-IV colorectal cancer will be enrolled.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with colorectal cancer (stage II-IV) at the Cross Cancer Institute (Edmonton, Alberta, Canada)

You may qualify if:

• 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

You may not qualify if:

• 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:
• 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
• Recent (within the past month) anti-cancer therapy

Sponsors & Collaborators

• University of Alberta: lead
• National Institutes of Health (NIH): collaborator

Study Sites (2)

University of Alberta

Edmonton, Alberta, T6G2E1, Canada

Location

Cross Cancer Institute

Edmonton, Alberta, Canada

Location

Related Publications (7)

• 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.

  PMID: 18539529 BACKGROUND

• Purcell 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.

  PMID: 27273068 BACKGROUND

• Moses 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.

  PMID: 14997196 BACKGROUND

• Skipworth 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.

  PMID: 21733604 BACKGROUND

• Reeves 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.

  PMID: 16704954 BACKGROUND

• Kyle 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.

  PMID: 22560739 BACKGROUND

• Purcell 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.

  PMID: 31225583 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Carla M Prado

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2017
• First Posted: April 27, 2017
• Study Start: April 5, 2016
• Primary Completion: August 18, 2022
• Study Completion: August 18, 2022
• Last Updated: September 6, 2023

Record last verified: 2023-08

Locations

CA (2)