Stage IV Colorectal Cancer
Conditions
Brief 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.
Interventions
PROCEDURENutritional counseling
Patients in the intervention-arm will receive individualized nutritional counseling 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 and a sufficient physical activity level.
Sponsors
Amsterdam UMC, location VUmc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥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 ≥ 3 * Long-term high dose of corticosteroids: ≥ three weeks ≥ ten milligram prednisolon or equivalent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in skeletal muscle area (cm2) between individualized nutritional counselling versus usual nutritional care | During 9 weeks of first line chemotherapy | will be measured with SliceOmatic software V5.0 (Tomovision) with use of routinely conducted CT scans for diagnostic and disease evaluation purposes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 counseling versus usual nutritional care | During 9 weeks of first line chemotherapy | — |
| Change in skeletal muscle area in patients with stage IV colorectal cancer during 20 weeks of first line chemotherapy between individualized nutritional counseling.versus usual nutritional care. | During 20 weeks of first line chemotherapy | Change in skeletal muscle area (cm2) between individualized nutritional counselling versus usual nutritional care |
| Composite of treatment toxicity, treatment intensity, treatment outcome, survival, physical functioning, quality of life and hand grip strength of both study arms | During 9 weeks and during 20 weeks of first line chemotherapy | — |
| 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). | During 9 weeks of first line chemotherapy | — |
Countries
Netherlands
Outcome results
None listed