The Impact of Metformin Administration on the Clinical Outcome of Stage IV Colon Cancer

Summary

Design: Prospective, randomized controlled trial Setting: Clinical Oncology and Nuclear Medicine, Ain Shams University Condition: Colorectal cancer Patients will be randomized into one of two groups: Group A: Patients will receive standard therapy FOLFOX PROTOCOL Group B: Patients will receive metformin (500 mg twice daily or 1000 mg once daily) on top of standard therapy Assessment: Baseline Assessment: * Patient Full History: Age, sex, smoking history, occupational history, medical history, concurrent diseases and medications. * Laboratory data: * Complete blood test * Liver functional test * Renal function test * Inflammatory Markers: Interleukin (IL)-6 EVERY 3 MONTH: CT/MRI /PET scan to detect the response to chemotherapy and progression , Quality of life by European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30. (EORTC QLQC30), Assessment of chemotherapy toxicity using CTACE 4.0 . Every 2 CYCLE: Lab examination (CBC, Liver function, Kidney function),CTACE SIDE EFFECTS EXAMINATION AFTER 6 MONTH : iL-6 LEVELS AFTER 1 YEAR : PFS AND OS

Timeline

Start

2020-04-15

Primary completion

2022-12-30

Completion

2022-12-30

Drugs

Indications