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Completed

NCT Number: NCT01998152

Individualized Nutritional Counselling During Chemotherapy for Colorectal Cancer (COLONUT)

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.

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Key information

Conditions

Stage IV Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VU Medical Center, Amsterdam, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in skeletal muscle area (cm2) between individualized nutritional counselling versus usual nutritional care

    Time frame: During 9 weeks of first line chemotherapy

    will be measured with SliceOmatic software V5.0 (Tomovision) with use of routinely conducted CT scans for diagnostic and disease evaluation purposes

Secondary outcomes

  1. 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

    Time frame: During 9 weeks of first line chemotherapy

  2. 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.

    Time frame: During 20 weeks of first line chemotherapy

    Change in skeletal muscle area (cm2) between individualized nutritional counselling versus usual nutritional care

  3. Composite of treatment toxicity, treatment intensity, treatment outcome, survival, physical functioning, quality of life and hand grip strength of both study arms

    Time frame: During 9 weeks and during 20 weeks of first line chemotherapy

  4. 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).

    Time frame: During 9 weeks of first line chemotherapy

Sponsors and collaborators

Lead sponsor

Amsterdam UMC, location VUmc

Other

Registry information

Official study title

The Effect of Individualized NUTritional Counselling on Muscle Mass and Treatment Outcome in Patients With Metastatic COLOrectal Cancer Undergoing Chemotherapy: the COLONUT Study

Acronym: COLONUT

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Nov 28, 2013
Registry last updated
Dec 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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