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Individualized Nutritional Counselling During Chemotherapy for Colorectal Cancer (COLONUT) (COLONUT)

Primary Purpose

Stage IV Colorectal Cancer

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Nutritional counseling
Sponsored by
Amsterdam UMC, location VUmc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stage IV Colorectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • VU Medical Center
  • Amphia Hospital
  • Reinier de Graaf
  • Ziekenhuis Gelderse Vallei
  • Spaarne hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Nutritional counseling

No intervention

Arm Description

Individualized nutritional counselling by a registered dietitian

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

Outcomes

Primary Outcome Measures

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

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
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
Composite of treatment toxicity, treatment intensity, treatment outcome, survival, physical functioning, quality of life and hand grip strength of both study arms
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).

Full Information

First Posted
November 11, 2013
Last Updated
December 20, 2018
Sponsor
Amsterdam UMC, location VUmc
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1. Study Identification

Unique Protocol Identification Number
NCT01998152
Brief Title
Individualized Nutritional Counselling During Chemotherapy for Colorectal Cancer (COLONUT)
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Amsterdam UMC, location VUmc

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage IV Colorectal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
107 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nutritional counseling
Arm Type
Experimental
Arm Description
Individualized nutritional counselling by a registered dietitian
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
Usual nutritional care by the oncologist. A dietitian is only involved when serious nutritional problems occur.
Intervention Type
Procedure
Intervention Name(s)
Nutritional counseling
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in skeletal muscle area (cm2) between individualized nutritional counselling versus usual nutritional care
Description
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 Outcome Measure Information:
Title
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
Title
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.
Description
Change in skeletal muscle area (cm2) between individualized nutritional counselling versus usual nutritional care
Time Frame
During 20 weeks of first line chemotherapy
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
M.A.E de van der Schueren, Dr.
Organizational Affiliation
Amsterdam UMC, location VUmc
Official's Role
Principal Investigator
Facility Information:
Facility Name
VU Medical Center
City
Amsterdam
ZIP/Postal Code
NL-1081 HV
Country
Netherlands
Facility Name
Amphia Hospital
City
Breda
ZIP/Postal Code
4819 EV
Country
Netherlands
Facility Name
Reinier de Graaf
City
Delft
ZIP/Postal Code
2625 AD
Country
Netherlands
Facility Name
Ziekenhuis Gelderse Vallei
City
Ede
ZIP/Postal Code
6716 RP
Country
Netherlands
Facility Name
Spaarne hospital
City
Hoofddorp
ZIP/Postal Code
NL-2134 TM
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
32037284
Citation
van der Werf A, Langius JAE, Beeker A, Ten Tije AJ, Vulink AJ, Haringhuizen A, Berkhof J, van der Vliet HJ, Verheul HMW, de van der Schueren MAE. The effect of nutritional counseling on muscle mass and treatment outcome in patients with metastatic colorectal cancer undergoing chemotherapy: A randomized controlled trial. Clin Nutr. 2020 Oct;39(10):3005-3013. doi: 10.1016/j.clnu.2020.01.009. Epub 2020 Jan 29.
Results Reference
derived
PubMed Identifier
25884881
Citation
van der Werf A, Blauwhoff-Buskermolen S, Langius JA, Berkhof J, Verheul HM, de van der Schueren MA. The effect of individualized nutritional counseling on muscle mass and treatment outcome in patients with metastatic colorectal cancer undergoing chemotherapy: a randomized controlled trial protocol. BMC Cancer. 2015 Mar 5;15:98. doi: 10.1186/s12885-015-1092-5.
Results Reference
derived

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Individualized Nutritional Counselling During Chemotherapy for Colorectal Cancer (COLONUT)

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