We hypothesize that patients in the intervention arm benefit from individualized nutritional counselling.
Bron
Verkorte titel
Aandoening
Advanced or recurrent colorectal cancer, stage IV
Ondersteuning
Onderzoeksproduct en/of interventie
Geen registraties gevonden.
Uitkomstmaten
Primaire uitkomstmaten
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
Achtergrond van het onderzoek
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
Doel van het onderzoek
We hypothesize that patients in the intervention arm benefit from individualized nutritional counselling.
Onderzoeksopzet
- Date of study inclusion
- During 9 weeks of first line chemotherapy
- During 20 weeks of first line chemotherapy
Onderzoeksproduct en/of interventie
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.
Publiek
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
Wetenschappelijk
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
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- 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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- 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
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiƫnten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL4086 |
NTR-old | NTR4223 |
CCMO | NL4534502913 |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |