Individualized Nutritional Counselling During Chemotherapy for Colorectal Cancer (COLONUT)

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of Individualized NUTritional Counselling on Muscle Mass and Treatment Outcome in Patients With Metastatic COLOrectal Cancer Undergoing Chemotherapy: the COLONUT Study

Conditions
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Stage IV Colorectal Cancer

Intervention / Treatment
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* Procedure: Nutritional counseling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nutritional counseling<br>Individualized nutritional counselling by a registered dietitian | Procedure: Nutritional counseling<br>* 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.<br>|
| No Intervention: No intervention<br>Usual nutritional care by the oncologist. A dietitian is only involved when serious nutritional problems occur. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in skeletal muscle area (cm2) between individualized nutritional counselling versus usual nutritional care | will be measured with SliceOmatic software V5.0 (Tomovision) with use of routinely conducted CT scans for diagnostic and disease evaluation purposes | During 9 weeks of first line chemotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Change in skeletal muscle area (cm2) between individualized nutritional counselling versus usual nutritional care | During 20 weeks of first line chemotherapy | 
| 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 |