Clinical trial · Interventional
Individualized Nutritional Counselling During Chemotherapy for Colorectal Cancer (COLONUT)
The Effect of Individualized NUTritional Counselling on Muscle Mass and Treatment Outcome in Patients With Metastatic COLOrectal Cancer Undergoing Chemotherapy: the COLONUT Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stage IV Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nutritional counseling | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Nutritional counseling
- description
- Individualized nutritional counselling by a registered dietitian
- interventionNames
- Procedure: Nutritional counseling
- type
- NO_INTERVENTION
- label
- No intervention
- description
- Usual nutritional care by the oncologist. A dietitian is only involved when serious nutritional problems occur.
Primary outcomes (1)
- measure
- Change in skeletal muscle area (cm2) between individualized nutritional counselling versus usual nutritional care
- timeFrame
- During 9 weeks of first line chemotherapy
- description
- will be measured with SliceOmatic software V5.0 (Tomovision) with use of routinely conducted CT scans for diagnostic and disease evaluation purposes
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDvan 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. PMID 32037284
- DERIVEDvan 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. PMID 25884881