No registrations found.
ID
Source
Brief title
Health condition
Colorectal and lungcancer
Sponsors and support
Uppsalalaan 12
3508 CT Utrecht, the Netherlands
Intervention
Outcome measures
Primary outcome
To assess protein intake at the end of the first treatment cycle
Secondary outcome
- Proportion of subjects with a protein intake above the lower limit of the ESPEN recommendations for protein intake
- Body weight
Background summary
study ended prematurely due to COVID. No summary available.
Study objective
a higher protein intake at the end of the first treatment cycle in patients with CRC or NSCLC undergoing first line treatment with chemo-, concurrent chemoradio- or immunotherapy who are receiving two servings of test product daily and who completed the study until the end of the first treatment cycle compared with standard of care.
Study design
Visits consist of: Screening, Baseline, Randomization, 1st day of each cycle, week 12 visit, week 13 follow up phone call.
Some questionnaires and diaries must be completed at home during the 13 week period. Timing depends on the treatment (2, 3 or 4 week treatment schedule)
Intervention
Duration of intervention: approximately 13 weeks
Intervention group: receiving two units of test product per day for oral intake for a period of approximately 13 weeks.
Control group: receiving standard of care, ie nutritional support as regularly provided by the hospital,
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 ¡Ý 18 years
5. Written informed consent
Exclusion criteria
1. Scheduled for first line chemotherapy, concurrent chemoradiotherapy or immunotherapy treatment starting ¡Ü4 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
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7297 |
| NTR-old | NTR7506 |
| Other | Nutricia : MPR16TA06151 |