Individualized Nutritional Counselling During Chemotherapy for Colorectal Cancer (COLONUT)

NCT01998152 | Completed DMC

• 1 other identifier: 2013230
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 5

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.

Conditions

Stage IV Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• 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

  During 9 weeks of first line chemotherapy

Secondary Outcomes (4)

• 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

• 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

Study Arms (2)

Nutritional counseling

EXPERIMENTAL

Individualized nutritional counselling by a registered dietitian

Procedure: Nutritional counseling

No intervention

NO INTERVENTION

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

Interventions

Nutritional counseling PROCEDURE

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.

Nutritional counseling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Chemotherapy in the previous three months
• WHO performance status ≥ 3
• Long-term high dose of corticosteroids: ≥ three weeks ≥ ten milligram prednisolon or equivalent

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead

Study Sites (5)

VU Medical Center

Amsterdam, NL-1081 HV, Netherlands

Location

Amphia Hospital

Breda, 4819 EV, Netherlands

Location

Reinier de Graaf

Delft, 2625 AD, Netherlands

Location

Ziekenhuis Gelderse Vallei

Ede, 6716 RP, Netherlands

Location

Spaarne hospital

Hoofddorp, NL-2134 TM, Netherlands

Location

Related Publications (2)

• 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.

  PMID: 32037284 DERIVED

• 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.

  PMID: 25884881 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• M.A.E de van der Schueren, Dr.

  Amsterdam UMC, location VUmc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Investigator dietetics and nutrition sciences Vumc

Study Record Dates

• First Submitted: November 11, 2013
• First Posted: November 28, 2013
• Study Start: November 1, 2013
• Primary Completion: December 1, 2018
• Study Completion: December 15, 2018
• Last Updated: December 21, 2018

Record last verified: 2018-12

Locations

NL (5)