The Impact of Metformin Administration on the Clinical Outcome of Stage IV Colon Cancer
Status:
COMPLETED
Trial end date:
2022-12-30
Target enrollment:
Participant gender:
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