The primary objective is to investigate the resting energy expenditure of children with a hematological, solid or brain malignancy at diagnosis and during treatment. The secondary objective is to explore the body composition, physical activity and…
ID
Source
Brief title
Condition
- Appetite and general nutritional disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Resting energy expenditure will be assessed using indirect calorimetry. Oxygen
consumption and carbon dioxide production will be measured. The respiratory
quotient will be derived from oxygen consumption and carbon dioxide production.
Secondary outcome
Body composition (fat and fat free mass) will be determined by bioelectrical
impedance analyses. Physical activity will be assessed using an Actigraph. The
intensity of physical activity (sedentary, light, moderate, and vigorous
physical activity), steps per day and metabolic equivalents of physical
activity will be derived.
Background summary
A balance between energy intake and energy requirement is crucial to maintain a
healthy body weight. Components of total energy expenditure include resting
energy expenditure, physical activity and diet induced thermogenesis,
representing respectively 50-70%, 15-40% and 10% of total energy expenditure in
children and adolescents. Since cancer and its treatment can influence all of
these components, estimation of energy requirement in patients with cancer is
challenging. Longitudinal data regarding resting energy expenditure in children
with cancer throughout treatment are limited and showed contradictory results.
Study objective
The primary objective is to investigate the resting energy expenditure of
children with a hematological, solid or brain malignancy at diagnosis and
during treatment. The secondary objective is to explore the body composition,
physical activity and dietary intake of these patients. Furthermore, blood
samples will be taken for cytokine analysis and validation of differences in
metabolism on cellular-level. The present study will also be used to explore
the feasibility of resting energy expenditure measurement before the start of
treatment in children with cancer. Moreover, the validity of body composition
measurement using the Tanita Body Composition Analyzer will be compared to the
Bodystat QuadScan 4000.
Study design
The present study will have a prospective observational design. Measurements of
resting energy expenditure, body composition, physical activity, and dietary
intake will be performed at diagnosis and two times during treatment. Patients
start participation in this study shortly after the start of treatment.
Study burden and risks
This study will yield valuable information to enable personalized support
regarding nutrition and physical activity in children with cancer. Performing
the measurements of resting energy expenditure, body composition, physical
activity and dietary intake is considered a minimal burden for children with
cancer. These data will be used to develop intervention studies aiming to
prevent under- and overfeeding and possible detrimental changes in body
composition during cancer treatment.
Heidelberglaan 25
Utrecht 3584 CS
NL
Heidelberglaan 25
Utrecht 3584 CS
NL
Listed location countries
Age
Inclusion criteria
-Diagnosed with cancer
-Treated with chemotherapy
-Between 4-18 years old at the start of treatment
-Ability to comprehend Dutch (both reading and writing)
Exclusion criteria
-Prior diagnosis of cancer
-Having oxygen delivery
-Inability to lay still for 20 minutes
-Inability of completing an overnight fast prior to the measurement
-Having an electric implant, such as a pacemaker
-Having a biosensor, such as a glucose meter
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 |
|---|---|
| Other | Netherlands Trial Register, NL7657 |
| CCMO | NL69551.041.19 |