Trial to investigate the effect of metformin treatment before and after surgery in patients with colon cancer
- Conditions
- MedDRA version: 20.0Level: PTClassification code 10009944Term: Colon cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Colon cancerTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2017-000722-35-DK
- Lead Sponsor
- Ismail Gögenur
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 48
-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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 33
-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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method