Individualized Nutritional Counselling During Chemotherapy for Colorectal Cancer (COLONUT)

N/ACompletedNCT01998152

Amsterdam UMC, location VUmc107 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

107

Conditions

Stage IV Colorectal Cancer

Interventions

Nutritional counselingPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (5)

VU Medical Center

Amsterdam, Netherlands

Amphia Hospital

Breda, Netherlands

Reinier de Graaf

Delft, Netherlands

Ziekenhuis Gelderse Vallei

Ede, Netherlands

Spaarne hospital

Outcomes

Primary Outcomes

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

Time frame: During 9 weeks of first line chemotherapy

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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).

Time frame: During 9 weeks of first line chemotherapy

Data from ClinicalTrials.gov

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