Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-25 @ 2:09 AM
NCT ID:
NCT05495360
Eligibility Criteria:
Inclusion Criteria:
1. Histologically proven CRC or histologically or cytologically proven NSCLC
2. Eligible and scheduled for at least 2 cycles of 4-week cycles of systemic treatment, 3 cycles of 3-week cycles of systemic treatment or 4 cycles of 2-week cycles of systemic treatment
3. At risk of malnutrition or malnourished \[PG-SGA-SF \> 4\]
4. Performance status ECOG 0 or 1
5. Weight loss grade 0-3 according to Martin et al1
6. \<11% weight loss in the past 6 months
7. Age ≥ 18 years
8. Written informed consent
Exclusion Criteria:
1. Presence of ileostoma or ileal pouch
2. GI-related or major surgery in 30 days prior to baseline
3. Severe hypercalcemia, i.e. total calcium level, corrected for albumin ≥ 14.0 mg/dL (3.5 mmol/L)
4. Use of ONS, enteral nutrition or parenteral nutrition within 14 days prior to entry into the study
5. Use of fish oil containing supplements, within 30 days prior to entry into the study or expected to use this during the study
6. Use of more than 200 iU/day of vitamin D containing supplements within 30 days prior to entry into the study or expected to use this during the study
7. Life expectancy of \< 3 months
8. Severe renal dysfunction (\<29 ml/min/1.73m2 eGRF or albumin:creatinine (ACR) \> 30) or hepatic encephalopathy
9. Allergy to cow's milk protein or fish, known protein sensitivity or suffering galactosemia
10. Known pregnancy or lactation
11. Current alcohol or drug abuse in opinion of the investigator
12. Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements
13. Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05495360
Study Brief:
Protocol Section:
NCT05495360