No registrations found.
ID
Source
Brief title
Health condition
Advanced or recurrent colorectal cancer, stage IV
Sponsors and support
Intervention
Outcome measures
Primary outcome
Change in skeletal muscle area (cm2)between individualized nutritional counselling versus usual nutritional care during 9 weeks of first line chemotherapy for stage IV colorectal cancer
Secondary outcome
- To compare change in total body lean body mass and segmental lean body mass (DEXA) in patients with stage IV colorectal cancer during 9 weeks of first line chemotherapy between individualized nutritional counselling versus usual nutritional care
- To compare change in skeletal muscle area in patients with stage IV colorectal cancer during 20 weeks of first line chemotherapy between individualized nutritional counselling versus usual nutritional care
- Explore treatment toxicity, treatment intensity, treatment outcome, survival, physical functioning, quality of life and handgrip strength of both study arms
- To explore associations of (changes in) muscle area with (changes in) mid-upper arm muscle circumference, whole body fat free mass (BIA) and whole body lean body mass (DEXA)
Background summary
The purpose is to study the effect of individualized nutritional counselling compared to usual nutritional care on cross-sectional muscle area in patients with stage IV colorectal cancer during first line chemotherapy. Secondary, effect on total lean body mass, treatment intensity, physical functioning, quality of life and survival will be studied. We hypothesize that patients in the intervention arm benefit from individualized nutritional counseling
Study objective
We hypothesize that patients in the intervention arm benefit from individualized nutritional counselling.
Study design
- Date of study inclusion
- During 9 weeks of first line chemotherapy
- During 20 weeks of first line chemotherapy
Intervention
Patients in the intervention-arm will receive individualized nutritional counselling by a registered dietitian during standard treatment with chemotherapy. The main goals of the nutritional intervention will be to enable every patient to achieve sufficient protein and energy intake with attention for sufficient intake of micronutrients.
P.O. Box 7057
M.A.E. Bokhorst - de van der Schueren, van
De Boelelaan 1117
Amsterdam 1007 MB
The Netherlands
NA
m.vanbokhorst@vumc.nl
P.O. Box 7057
M.A.E. Bokhorst - de van der Schueren, van
De Boelelaan 1117
Amsterdam 1007 MB
The Netherlands
NA
m.vanbokhorst@vumc.nl
Inclusion criteria
- Age older than 18 years
- Stage IV colorectal cancer
- Scheduled for treatment with first line chemotherapy
- Either CAPOX(-B), FOLFOX(-B) or capecitabine (-B)
- CT scan suitable for evaluating muscle mass at L3 level
- Understanding of the Dutch language
- Able and willing to give written informed consent
Exclusion criteria
- Chemotherapy in the previous three months
- WHO performance status higher than 3
- Long-term high dose of corticosteroids: longer than three weeks, more than 10 milligram prednisolon or equivalent
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4086 |
| NTR-old | NTR4223 |
| CCMO | NL45345.029.13 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON44653 |