Individualized nutritional counselling duringchemotherapy for colorectal cancer (COLONUT)
- Conditions
- Advanced or recurrent colorectal cancer, stage IV
- Registration Number
- NL-OMON22047
- Lead Sponsor
- Vu Medical Center Amsterdam
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 110
Inclusion Criteria
Age older than 18 years
- Stage IV colorectal cancer
Exclusion Criteria
- Chemotherapy in the previous three months
- WHO performance status higher than 3
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method - 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 <br /><br>- 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<br /><br>- Explore treatment toxicity, treatment intensity, treatment outcome, survival, physical functioning, quality of life and handgrip strength of both study arms<br /><br>- 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)<br /><br />