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 @ 3:28 PM
Ignite Modification Date:
2025-12-24 @ 3:28 PM
NCT ID:
NCT06826092
Eligibility Criteria:
Inclusion Criteria:
1. Aged between 20 and 90 years old
2. Patients diagnosed with metastatic colorectal cancer who is going to receive FOLFIRI chemotherapy
3. Female must not be planning to become pregnant or breastfeeding, and not pregnant at any point during treatment. (Contraception is required to participate in this trial)
4. Those without major physiological diseases (example of major cardiovascular disease is acute myocardial infarction; example of major cerebrovascular disease is acute stroke, malignant hypertension, acute kidney failure, acute liver failure)
5. Those who are not allergic to the relevant drugs required for the test
6. Those who can follow the doctor's order to take the medicine
7. Subjects must be willing to sign the consent form
8. Blood sugar level above 80 mg/dL
Exclusion Criteria:
Subjects who meet any of the following exclusion conditions are not allowed to join the trial
1. Patients other than the above-mentioned main inclusion criteria.
2. Non-native speakers
3. Known allergy to metformin or any of its components.
4. Severe instability in diabetes (ketoacidosis).
5. Blood sugar level lower than 80 mg/dL
6. Heart failure, respiratory insufficiency.
7. inadequate hematopoietic function defined as below:
* hemoglobin \< 9 g/dL;
* absolute neutrophil count (ANC) \< 1,500/mm3;
* platelet count \< 100,000/mm3;
8. inadequate organ functions defined as below:
* total bilirubin \> 2 times upper limit of normal (ULN);
* hepatic transaminases (ALT and AST) \> 2.5 x ULN;
* creatinine \> 1.5 x ULN;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
90 Years
Study:
NCT06826092
Study Brief:
Protocol Section:
NCT06826092