kanker cachexie, ondervoeding bij kanker Cancer cachexia cancer related body weight and muscle loss
Conditions
Interventions
The test group will be asked to take the medical nutrition supplement twice per
day, during the first 3 cycles of CAPOX-B treatment. The control group receives
the same medical CAP-containing treatm
Sponsors
Nutricia
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Histologically proven colorectal cancer 2. Presence of distant metastases 3. Eligible and scheduled for first line treatment with CAP-containing systemic treatment 4. Performance status (WHO/ECOG) of 0 or 1 5. Age >= 18 years 6. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Presence of ileostoma or ileal pouch 2. Malnutrition Univeral Screening Tool (MUST) score of >=2, indicating high risk of malnutrition 3. Body mass index = 12.0 mg/dL 7. Use of fish oil containing supplements or usual consumption of fatty fish > 2x per week, within 3 weeks prior to entry into the study or expected use during the study 8. Known pregnancy or lactation 9. Current alcohol, drug or medication abuse in opinion of the investigator 10. Investigator*s uncertainty about the willingness or ability of the patient to comply with the protocol requirements 11. Participation in any other intervention studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compliance to nutritional test product intake as measured by: - The eicosapentaenoic acid (EPA) concentration in the phospholipid fraction of the erythrocyte membrane [% of total fatty acids] after the first 3 cycles of CAP-containing treatment (measured in both study groups) - Test product intake as recorded by the patient in a daily diary after the first 3 cycles of CAP-containing treatment. The actual test product intake after the first 3 cycles of CAP-containing treatment as compared to the (as per protocol) recommended intake will be evaluated. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Body weight [kg] - Body composition from CT scan: skeletal muscle mass; fat mass; muscle density - Quality of Life and symptoms: European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC) QLQ-C30 and EORTC QLQ-CR29 - Performance status (WHO/ECOG) - Dietary intake by 3-day dietary record - Blood parameters - Evaluation of study participation including experienced changes in sensory aspects and taste perception. | — |
Countries
Netherlands
Outcome results
None listed