Using Metformin with FOLFIRI chemotherapy for metastatic colorectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effectiveness of Metformin in improving progression-free survival (PFS) in patients with metastatic colorectal cancer who are receiving FOLFIRI chemotherapy. Participants will be divided into two groups: one receiving FOLFIRI alone and the other receiving FOLFIRI combined with Metformin. The study also aims to assess overall survival (OS) and disease control rate (DCR) among the participants. The trial will include patients aged 20 to 90 who meet specific health criteria and are willing to adhere to treatment protocols.

Why it matters

Who can join: the full rules

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;

Where it's running

• Chung-Ho Memorial Hospital, Kaohsiung Medical University:
  Kaohsiung City, Taiwan Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.