The effect of individualized NUTritional counselling on muscle mass and treatment outcome in patients with metastatic COLOrectal cancer undergoing chemotherapy: the COLONUT study

The effect of individualized NUTritional counselling on muscle mass and treatment outcome in patients with metastatic COLOrectal cancer undergoing chemotherapy: the COLONUT study - COLONUT

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON44653

Enrollment

110

Registered

2013-09-27

Start date

2013-12-30

Completion date

Unknown

Last updated

2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cancer Neoplasms

Interventions

Patients in the intervention group will receive individualized nutritional counselling by a registered dietitian during a period of approximately eighteen weeks (6 cycles of 3-weekly chemotherapy or

if it appears that nutritional goals cannot be met by regular food, oral nutritional supplements or tube feeding will be offered. Patients in the control-arm receive usual nutritional care.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: -Age >=18 years; -Stage IV colorectal cancer; -Scheduled for treatment with first-line chemotherapy; -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

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

Design outcomes

Primary

Measure	Time frame
Change in skeletal muscle area (cm2) will be measured with SliceOmatic software V5.0 (Tomovision) with use of routinely conducted CT scans for diagnostic and disease evaluation purposes.	—

Secondary

Measure	Time frame
To compare 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 counselling versus usual nutritional care. To compare change in skeletal muscle area in patients with stage IV colorectal cancer during 20 weeks of first-line chemotherapy between individualized nutritional counselling.versus ususal nutritional care. To explore treatment toxicity, treatment intensity, treatment outcome, survival, physical functioning, quality of life and handgrip strength of both study arms. To explore 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).	—

Measure

Time frame

To compare 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 counselling versus usual nutritional care. To compare change in skeletal muscle area in patients with stage IV colorectal cancer during 20 weeks of first-line chemotherapy between individualized nutritional counselling.versus ususal nutritional care. To explore treatment toxicity, treatment intensity, treatment outcome, survival, physical functioning, quality of life and handgrip strength of both study arms. To explore 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).

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)