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:
2025-12-24 @ 4:26 PM
Ignite Modification Date:
2025-12-24 @ 4:26 PM
NCT ID:
NCT07255066
Eligibility Criteria:
Inclusion Criteria:
* Participants with stage III-IV lung and/or colorectal cancer undergoing systemic anti-cancer treatment (SACT) or starting SACT within the next 4 weeks \*with non-curative intent
* Participants aged 18 or older
* Participants at nutritional risk defined as a BMI \<20 kg/m2 and/or weight loss between 5-10% in the previous 6 months\*\*
* Participants with systemic inflammation within 28 days of screening (e.g. CRP \>10 mg/dL)
* Participants with an ECOG-PS\*\*\* score of 0, 1 or 2
* Participants willing and able to give written informed consent
Exclusion Criteria:
* Participants with a recent history of tumour resection (within 12 months)
* Participants who have lost \>10% body weight in the previous 6 months before baseline - observed or participant reported.
* Participants with severe renal or hepatic failure or an intolerance to any of the ingredients of the study product
* Participants who are using dietary counselling, ONS or any form of artificial feeding at the time of recruitment
* Unable to adhere to either arm of the trial and appropriate requirements
* Contraindication to ONS including a lactose intolerance
* Females who are pregnant or of childbearing potential and not using adequate contraception
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07255066
Study Brief:
Protocol Section:
NCT07255066