kanker cachexie, ondervoeding bij kanker cancer cachexia weight- and muscle loss
Conditions
Interventions
The test group will be receiving daily 2 servings of a low volume, energy dense 
and high protein oral nutritional supplement during 12 weeks of first line 
treatment. The control group will be receiving standard of care.
Sponsors
Nutricia Research
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Histologically proven CRC stage IIB, III or IV or histologically or cytologically proven NSCLC stage III or IV 2. Eligible and scheduled for first line chemotherapy, concurrent chemoradiotherapy or immunotherapy treatment with a planned duration of at least 12 weeks 3. Performance status Eastern Cooperative Oncology Group (ECOG) score 0 or 1 4. Age >= 18 years 5. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Scheduled for first line chemotherapy, concurrent chemoradiotherapy or immunotherapy treatment starting <=4 days after randomization 2. Received >10 doses of radiotherapy within 2 months prior to the study 3. Weight loss >10% in the last 6 months 4. Body Mass Index < 20.0 kg/m2 5. Life expectancy < 3 months 6. Prescription of oral nutritional supplementation (ONS) before start of first line treatment based on hospital*s standard practice 7. Presence of ileostoma or ileal pouch 8. Contra-indications to oral feeding, high protein nutrition or to the test product (including galactosaemia) in the opinion of the investigator 9. Known pregnancy or lactation 10. Current alcohol or drug abuse in the opinion of the investigator 11. Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements 12. Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The average protein intake per day corrected for baseline after 1 cycle of first line treatment with chemo-, concurrent chemoradio- or immunotherapy (3-day food diary) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary and exploratory outcomes of the study are: • Body weight • Proportion of subjects with a protein intake >=1.0 g/kg/day (3-day food diaries + 1-day food diaries • Total dietary energy intake, macronutrient intake, micronutrient intake (3-day food diaries + 1-day food diaries) • Factors impacting nutritional intake (question with each food diary) • Taste and smell changes (questionnaire) • Health-related Quality of Life (EORTC QLQ-C30 and QLQ-CAX24, in a subgroup) • Tolerance questionnaire • Performance status (ECOG) • Anti-cancer treatment adherence and dose-limiting toxicities • Body composition from CT scan (optional, when data available from routine clinical care) | — |
Countries
Netherlands
Outcome results
None listed