Status:
COMPLETED
Metformin Treatment for Colon Cancer
Lead Sponsor:
Zealand University Hospital
Conditions:
Colon Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ...
Detailed Description
Background: Colorectal cancer (CRC) is the third most common cancer worldwide and more than 5000 patients are diagnosed each year in Denmark. Metformin is the drug of choice for treatment of type 2 d...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 10 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 4 2021
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT03359681
Start Date
July 10 2018
End Date
October 4 2021
Last Update
March 3 2022
Active Locations (1)
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1
Department of Surgery, Slagelse Hospital
Slagelse, Denmark, 4200