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 @ 12:18 AM
Ignite Modification Date:
2025-12-25 @ 12:18 AM
NCT ID:
NCT05677958
Eligibility Criteria:
Inclusion Criteria:
* Histologically proven CRC stage IIB, III or IV or histologically or cytologically proven NSCLC stage III or IV
* Eligible and scheduled for first line chemotherapy, concurrent chemoradiotherapy or immunotherapy treatment with a planned duration of at least 12 weeks
* Performance status Eastern Cooperative Oncology Group (ECOG) score 0 or 1
* Age ≥ 18 years
* Written informed consent
Exclusion Criteria:
* Scheduled for first line chemotherapy, concurrent chemoradiotherapy or immunotherapy treatment starting ≤4 days after randomization
* Received radiotherapy within 2 months prior to the study
* Weight loss \>10% in the last 6 months
* Body Mass Index \< 20.0 kg/m2
* Life expectancy \< 3 months
* Prescription of oral nutritional supplementation (ONS) before start of first line treatment based on hospital's standard practice
* Presence of ileostoma or ileal pouch
* Contra-indications to oral feeding, high protein nutrition or to the test product (including galactosaemia) in the opinion of the investigator
* Known pregnancy or lactation
* Current alcohol or drug abuse in the opinion of the investigator
* Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
* 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:
NCT05677958
Study Brief:
Protocol Section:
NCT05677958