Individualized Nutritional Counselling During Chemotherapy for Colorectal Cancer (COLONUT)

Not Applicable

Completed

• Conditions: Stage IV Colorectal Cancer
• Interventions: Procedure: Nutritional counseling

• Registration Number: NCT01998152
• Lead Sponsor: Amsterdam UMC, location VUmc

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-11-11
• Study First Submitted QC: 2013-11-22
• Study First Posted: 2013-11-28
• Status Verified: 2018-12
• Primary Completion: 2018-12
• Study Completion: 2018-12-15
• Last Update Submitted: 2018-12-20
• Last Update Posted: 2018-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nutritional counseling	Nutritional counseling	Individualized nutritional counselling by a registered dietitian

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	will be measured with SliceOmatic software V5.0 (Tomovision) with use of routinely conducted CT scans for diagnostic and disease evaluation purposes

Secondary Outcome Measures

Name	Time	Method
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
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
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

Trial Locations

Locations (5)

VU Medical Center; 🇳🇱 Amsterdam, Netherlands

Amphia Hospital; 🇳🇱 Breda, Netherlands

Reinier de Graaf; 🇳🇱 Delft, Netherlands

Ziekenhuis Gelderse Vallei; 🇳🇱 Ede, Netherlands

Spaarne hospital; 🇳🇱 Hoofddorp, Netherlands