The first aim of this study is to investigate and validate energy expenditure using DLW in colorectal cancer patients before and after a liver resection and to estimate energy balance from the change in body composition. The second main aim of the…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
peri-operational energy balance + cancer cachexia
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters are energy balance (calculated as difference between food
intake and energy expenditure and from changes in body composition), body
composition (measured using DEXA, CT and BIA), metabolic markers (measured in
fat and muscle biopsies), biochemical markers (measured in blood/serum), muscle
function parameters (grip strength and measured in a biopsy) and gene
expression (transcriptomic and PCR analyses of fat and muscle biopsies).
Secondary outcome
Not applicable
Background summary
Undernutrition in hospitalized patients defined as low BMI (BMI < 18.5) or
unintended weight loss, poses a risk for increased morbidity and mortality. The
prevalence of undernutrition in surgical patients is estimated to be 25%-40%.
To reduce undernutrition, optimal perioperative nutritional support in
hospitalized patients is needed. Therefore, an accurate estimate of energy
expenditure during different stages in the peri-operative process is relevant.
In cancer patients, cachexia plays an additional role in the
maintenance of energy balance and protein balance. Cachexia is a complex
metabolic syndrome characterized by clinically relevant loss of muscle mass
with or without loss of fat mass. In cachexia, restoring the balance between
energy intake and energy consumption is key to a proper treatment program1.
Currently, not much is known on the additional negative effects of a surgical
procedure on energy metabolism in patients with a tumor that can induce
cachexia.
Study objective
The first aim of this study is to investigate and validate energy expenditure
using DLW in colorectal cancer patients before and after a liver resection and
to estimate energy balance from the change in body composition.
The second main aim of the study is to investigate the relation between
energy metabolism, changes in body composition as measured by repeated CT-scans
and the functional and metabolic parameters influencing cachexia.
Study design
Observational study
Study burden and risks
The condition of the patients and the planned operation can cause adverse
effects. However, we expect no additional risk for the subjects due to the
proposed measurements. For the sampling of blood, there is a small risk of
bruising. Harvest of biopsies occurs during the planned operation and is not
expected to cause a significant increase in burden for the patient. All other
measurements are non-invasive, observational measurements with no risk of any
harmful side effects.
De Valk, Building 304, Dreijenlaan 2
Wageningen 6703 HA
NL
De Valk, Building 304, Dreijenlaan 2
Wageningen 6703 HA
NL
Listed location countries
Age
Inclusion criteria
• Colon cancer with liver metastases.
• Eligible for a liver resection procedure.
Exclusion criteria
• Being abroad for more than one week during the month preceding the surgery
• Suffering from malabsorption
• Having an artificial cardiac pacemaker
• Laparoscopic surgery
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL50557.081.14 |