Design: Prospective, randomized controlled clinical trial Setting: at Minia University Hospital and Minia Oncology Institute. Condition: Colorectal cancer. To be eligible for participation, patients must meet the following criteria: 1. Histologically confirmed diagnosis of rectal adenocarcinoma. 2. Age starting from 18 and older. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. 4. Adequate organ function (renal, hepatic, and hematological) 5. Signed informed consent. Patients will be randomized into two groups: Group A: Patients will receive standard chemoradiotherapy(CRT). Group B: Patients will self-administer 1000mg of metformin twice daily by mouth: 1. beginning 1-2 weeks before standard CRT. 2. during standard CRT. 3. until 30 days after the end of standard CRT.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
85
1000mg of metformin twice daily by mouth
Minia Oncology Center
Minya, Egypt, Egypt
Minia University Hospital
Minya, Egypt, Egypt
Pathological Complete Response (pCR) rate
The Main outcome is to assess the use of metformin to improve pathological complete response (pCR) rates among non-diabetic participants undergoing standard neoadjuvant CRT for rectal cancer. The primary outcome will be measured by the pathological complete response rate after completion of the study treatment.
Time frame: 6 months
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