Clinical trial NCT01998152: Individualized Nutritional Counselling During Chemotherapy for Colorectal Cancer (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
Overall status: COMPLETED
Phase: NA
Conditions: Stage IV Colorectal Cancer
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
First posted: 2013-11-28
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in skeletal muscle area (cm2) between individualized nutritional counselling versus usual nutritional care
timeFrame: During 9 weeks of first line chemotherapy
Secondary outcomes:
measure: 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
timeFrame: During 9 weeks of first line chemotherapy
measure: 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.
timeFrame: During 20 weeks of first line chemotherapy
measure: Composite of treatment toxicity, treatment intensity, treatment outcome, survival, physical functioning, quality of life and hand grip strength of both study arms
timeFrame: During 9 weeks and during 20 weeks of first line chemotherapy
measure: 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).
timeFrame: During 9 weeks of first line chemotherapy
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: VU Medical Center
city: Breda
country: Netherlands
facility: Amphia Hospital
city: Delft
country: Netherlands
facility: Reinier de Graaf
city: Ede
country: Netherlands
facility: Ziekenhuis Gelderse Vallei
city: Hoofddorp
country: Netherlands
facility: Spaarne hospital
Study officials:
affiliation: Amsterdam UMC, location VUmc
name: M.A.E de van der Schueren, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.