Individualized Nutritional Counselling During Chemotherapy for Colorectal Cancer (COLONUT)

Stage IV Colorectal Cancer Clinical Trial

— COLONUT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01998152
• Other study ID #: 2013230
• Status: Completed
• Phase: N/A
• Start date: November 2013
• Est. completion date: December 15, 2018

Study information

• Verified date: December 2018
• Source: VU University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: December 15, 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Stage IV Colorectal Cancer

Intervention

Procedure:
• Nutritional 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.

Locations

Country	Name	City	State
Netherlands	VU Medical Center	Amsterdam
Netherlands	Amphia Hospital	Breda
Netherlands	Reinier de Graaf	Delft
Netherlands	Ziekenhuis Gelderse Vallei	Ede
Netherlands	Spaarne hospital	Hoofddorp

Sponsors (1)

Lead Sponsor	Collaborator
VU University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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