Individualized Nutritional Counselling During Chemotherapy for Colorectal Cancer (COLONUT)

Sponsor

Amsterdam UMC, location VUmc (Other)

Overall Status

Completed

CT.gov ID

NCT01998152

Collaborator

(none)

107

Enrollment

Locations

Arms

61.4

Duration (Months)

21.4

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stage IV Colorectal Cancer	Procedure: Nutritional counseling	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

107 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Care Provider)

Primary Purpose:

Treatment

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

Study Start Date :

Nov 1, 2013

Actual Primary Completion Date :

Dec 1, 2018

Actual Study Completion Date :

Dec 15, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Nutritional counseling Individualized nutritional counselling by a registered dietitian	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.
No Intervention: No intervention Usual nutritional care by the oncologist. A dietitian is only involved when serious nutritional problems occur.

Arm

Intervention/Treatment

Experimental: Nutritional counseling

Individualized nutritional counselling by a registered dietitian

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.

No Intervention: No intervention

Usual nutritional care by the oncologist. A dietitian is only involved when serious nutritional problems occur.

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	VU Medical Center	Amsterdam	Netherlands	NL-1081 HV
2	Amphia Hospital	Breda	Netherlands	4819 EV
3	Reinier de Graaf	Delft	Netherlands	2625 AD
4	Ziekenhuis Gelderse Vallei	Ede	Netherlands	6716 RP
5	Spaarne hospital	Hoofddorp	Netherlands	NL-2134 TM

Sponsors and Collaborators

Amsterdam UMC, location VUmc

Investigators

Principal Investigator: M.A.E de van der Schueren, Dr., Amsterdam UMC, location VUmc

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

M.A.E van Bokhorst - de van der Schueren, Dr., Senior Investigator dietetics and nutrition sciences Vumc, Amsterdam UMC, location VUmc

ClinicalTrials.gov Identifier:

NCT01998152

Other Study ID Numbers:

2013230

First Posted:

Nov 28, 2013

Last Update Posted:

Dec 21, 2018

Last Verified:

Dec 1, 2018

Additional relevant MeSH terms:

Colorectal Neoplasms

Study Results

No Results Posted as of Dec 21, 2018