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 @ 3:55 AM
Ignite Modification Date:
2025-12-25 @ 3:55 AM
NCT ID:
NCT06902402
Eligibility Criteria:
Inclusion Criteria:
1. Patients receiving chemotherapy and/or radiotherapy, or immunotherapy, or targeted therapy;
2. Patient with diagnosed cancer of any type (e.g., head and neck cancer, lung cancer, digestive tract cancer, breast cancer);
3. Patient with or at risk of malnutrition defined as meeting Malnutrition Universal Screening Tool (MUST) with score ≥2;
4. Capable of using oral nutritional supplementation;
5. Written informed consent from patient.
Exclusion Criteria:
1. Patient with documented diagnosis of liver, kidney or heart disease in the hospital's electronic medical record (EMR); severity of disease evaluated by Investigator as not being suitable to participate in this study;
2. Current alcohol or substance abuse as assessed by Investigator;
3. Patient had a stroke in the past year and is after Investigator assessment judged as not yet clinically stable at the time of screening;
4. Patients who are diagnosed with mental illness or depression assessed by the Investigator as too severe for being suitable to participate in this study;
5. Pregnant or breastfeeding woman;
6. Allergic to any ingredient of the investigational products;
7. Patients receiving or having received standard (not disease specific) oral nutritional supplements (ONS), standard enteral formula/tube feeding or standard parenteral cancerspecific nutrition supplements in the last 3 days;
8. Patients receiving or having received ONS, enteral formula/tube feeding or parenteral nutrition with high fish oil or high EPA/DHA content (above 1 g/day) in the last 28 days;
9. Current use of medication, food supplements or ONS containing more than 500 mg of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)/day or fish oil capsules/supplements containing more than 500 mg EPA and DHA/day at screening;
10. Transfusion of blood products within 1 week before screening;
11. Surgery scheduled during the trial;
12. Participation in other clinical trials using investigational drugs within 14 days before the start of the trial or during the trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06902402
Study Brief:
Protocol Section:
NCT06902402