Metformin Treatment for Colon Cancer

• Status: Recruiting
• Trial end date: 2022-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a double-blinded placebo controlled randomized trial examining the effect of metformin in non-diabetic patients with colon cancer on cell growth, immunological and metabolic changes. Patients are randomized to receive metformin 20 days before and 10 days after surgery. Tumor samples are examined for changes in level of cell growth and the composition of tumor cells in the tumor is examined. Blood samples are assessed for immunological markers and insulin resistance is measured. Cell proliferation, migration and adhesion are also examined in vitro by adding plasma obtained from the patients to colon cancer cell lines grown in culture.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zealand University Hospital
• Treatments: Metformin

Criteria

Inclusion Criteria:

• Patients with adenocarcinoma of the colon planned for elective curative intended surgery at Slagelse hospital

• Age of 18 or above

• Must be able to understand and sign informed content

• Sufficient amount of representative tumor material from the biopsies taken at the initial colonoscopy must be present

Exclusion Criteria:

• Patients diagnosed with diabetes mellitus

• Patients who are receiving or have received metformin or other oral antidiabetics

• Impaired kidney function (eGFR < 60mL/min)

• Severe liver disease (defined as transaminases above X 3 normal levels)

• Participation in another pharmacological intervention trial

• Predictable poor compliance (for instance not speaking fluent Danish, mentally impaired)

• Presenting with metastatic disease

• Patients undergoing neoadjuvant chemotherapy

• Pregnancy or lactation (fertile women must have a negative serum or urine pregnancy test to participate)

• Fertile women who do not use safe contraception during the study period.

• Allergy to metformin or placebo