Clinical trial · Observational
Determining Energy Needs in Colorectal Cancer
Resting Energy Expenditure in Cancer - Associations With Body Composition, Dietary Intake, and Exercise Habits
NCT03131921CI-TRIAL-00069338RECODEcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Colorectal cancer
- description
- No intervention. Patients with newly diagnosed stage II-IV colorectal cancer will be enrolled.
Primary outcomes (1)
- measure
- Resting energy expenditure
- timeFrame
- At baseline, before or immediately beginning cancer treatment
- description
- To assess resting energy expenditure using indirect calorimtery
Secondary outcomes (2)
- measure
- Body composition
- timeFrame
- At baseline, before or immediately beginning cancer treatment
- description
- To assess skeletal muscle and adipose tissue using computerized tomography images taken before beginning cancer treatment
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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
References
Publications (7)
- BACKGROUNDPrado 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
- BACKGROUNDPurcell 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
- BACKGROUNDMoses 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
- BACKGROUNDSkipworth 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
- BACKGROUNDReeves 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
- BACKGROUNDKyle 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