The effect of individualized NUTritional counselling on muscle mass and treatment outcome in patients with metastatic COLOrectal cancer undergoing chemotherapy: the COLONUT study
Completed
- Conditions
- cancerNeoplasms1000301810017991
- Registration Number
- NL-OMON44653
- Lead Sponsor
- Vrije Universiteit Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 110
Inclusion Criteria
-Age >=18 years;
-Stage IV colorectal cancer;
-Scheduled for treatment with first-line chemotherapy;
-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 >= 3;
-Long-term high dose of corticosteroids: >= three weeks >= ten milligram prednisolon or equivalent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Change in skeletal muscle area (cm2) will be measured with SliceOmatic software<br /><br>V5.0 (Tomovision) with use of routinely conducted CT scans for diagnostic and<br /><br>disease evaluation purposes. </p><br>
- Secondary Outcome Measures
Name Time Method <p>To compare change in total body lean body mass and segmental lean body mass<br /><br>(DEXA) in patients with stage IV colorectal cancer during 9 weeks of first-line<br /><br>chemotherapy between individualized nutritional counselling versus usual<br /><br>nutritional care.<br /><br><br /><br>To compare change in skeletal muscle area in patients with stage IV colorectal<br /><br>cancer during 20 weeks of first-line chemotherapy between individualized<br /><br>nutritional counselling.versus ususal nutritional care.<br /><br><br /><br>To explore treatment toxicity, treatment intensity, treatment outcome,<br /><br>survival, physical functioning, quality of life and handgrip strength of both<br /><br>study arms.<br /><br><br /><br>To explore associations of (changes in) muscle area with (changes in) mid-upper<br /><br>arm muscle circumference, whole body fat free mass (BIA) and whole body lean<br /><br>body mass (DEXA). </p><br>