Clinical trial · Interventional
Metformin Treatment for Colon Cancer
Perioperative Metformin Treatment for Colon Cancer, a Randomized Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Metformin Hydrochloride | Drug | Metformin | ALIAS |
| Placebo oral capsule | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- metformin hydrochloride
- description
- metformin, encapsulated tablet, 500mg 3 times a day for 30 days.
- interventionNames
- Drug: Metformin Hydrochloride
- type
- PLACEBO_COMPARATOR
- label
- placebo oral capsule
- description
- placebo, encapsulated tablet, 500mg 3 times a day for 30 days.
- interventionNames
- Drug: Placebo oral capsule
Primary outcomes (1)
- measure
- Expression of Ki67 on tumor samples
- timeFrame
- colonoscopy (baseline) and at time of operation (after intervention)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDColov Tauby EP, Bojesen RD, Grube C, Miedzianogora REG, Buzquurz F, Fransgaard T, Knop FK, Gogenur I. Perioperative Metformin Treatment to Reduce Postoperative Hyperglycemia After Colon Cancer Surgery: A Randomized Clinical Trial. Dis Colon Rectum. 2024 Nov 1;67(11):1403-1412. doi: 10.1097/DCR.0000000000003426. Epub 2024 Jul 31. PMID 39437217