Individualized Nutritional Counselling During Chemotherapy for Colorectal Cancer (COLONUT)
NCT ID: NCT01998152
Last Updated: 2018-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
107 participants
INTERVENTIONAL
2013-11-30
2018-12-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Nutritional counseling
Individualized nutritional counselling by a registered dietitian
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
Usual nutritional care by the oncologist. A dietitian is only involved when serious nutritional problems occur.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* WHO performance status ≥ 3
* Long-term high dose of corticosteroids: ≥ three weeks ≥ ten milligram prednisolon or equivalent
18 Years
ALL
No
Sponsors
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Amsterdam UMC, location VUmc
OTHER
Responsible Party
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M.A.E van Bokhorst - de van der Schueren, Dr.
Senior Investigator dietetics and nutrition sciences Vumc
Principal Investigators
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M.A.E de van der Schueren, Dr.
Role: PRINCIPAL_INVESTIGATOR
Amsterdam UMC, location VUmc
Locations
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VU Medical Center
Amsterdam, , Netherlands
Amphia Hospital
Breda, , Netherlands
Reinier de Graaf
Delft, , Netherlands
Ziekenhuis Gelderse Vallei
Ede, , Netherlands
Spaarne hospital
Hoofddorp, , Netherlands
Countries
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References
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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.
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.
Other Identifiers
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2013230
Identifier Type: -
Identifier Source: org_study_id