Individualized Nutritional Counselling During Chemotherapy for Colorectal Cancer (COLONUT)

Amsterdam UMC, location VUmc

Status: Completed

Conditions: Stage IV Colorectal Cancer

Treatments: Procedure: Nutritional counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT01998152

2013230

Details and patient eligibility

About

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.

Enrollment: 107 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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107 participants in 2 patient groups

Nutritional counseling

Experimental group

Description:

Individualized nutritional counselling by a registered dietitian

Treatment:

Procedure: Nutritional counseling

No intervention

No Intervention group

Description:

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