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,…
ID
Source
Brief title
Condition
- Appetite and general nutritional disorders
- Gastrointestinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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).
Background summary
Malnutrition is a major issue in patients with advanced colorectal cancer
undergoing chemotherapy. An unfavourable body composition with low muscle mass
is associated with reduced functional status, more severe toxicity of treatment
and reduced survival. Seventy percent of patients with advanced colorectal
cancer already have a low muscle mass before start of treatment, and muscle
mass decreases during treatment. Protein supplementation and physical activity
are known to induce muscle protein anabolism, however it is unclear whether
this regime is also effective in patients with metastatic colorectal cancer
during chemotherapy.
Study objective
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.
Study design
Randomized controlled trial
Intervention
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 8 cycles of 2-weekly
chemotherapy). The main goals of the nutritional intervention will be to
enable every patient to achieve at least sufficient protein and energy intake
with attention for sufficient intake of micronutrients and a sufficient
physical activity level. Individualized nutritional counselling consists of an
energy and protein rich diet using regular food; 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.
Study burden and risks
We hypothesize that patients in the intervention arm benefit from
individualized nutritional counselling. No harm is expected of the intervention
and measurements conducted in this study. Participants have three study visits
which are preferably planned on days patients have to visit the hospital for
another appointment. They keep a food diary and wear an accelerometer three
days before the appointment in the hospital (at baseline this could be
substituted by a 48h dietary recall and LAPAQ questionnaire). The participants
in the intervention-arm have no extra visits as the dietitian will visit them
at days they attend the hospital for treatment.
De Boelelaan 1117
Amsterdam 1081HV
NL
De Boelelaan 1117
Amsterdam 1081HV
NL
Listed location countries
Age
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
-Chemotherapy in the previous three months;
-WHO performance status >= 3;
-Long-term high dose of corticosteroids: >= three weeks >= ten milligram prednisolon or equivalent
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT01998152 |
| CCMO | NL45345.029.13 |
| OMON | NL-OMON22047 |