drugset / Trial / NCT06728982

Impact Of Metformin In Rectal Cancer Patients

NCT06728982

Phase 2/3 Completed 85 enrolled Minia University
RandomizedParallel-groupSingle-blindTreatment

Summary

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.

Timeline

Start
2024-05-01
Primary completion
2025-06-15
Completion
2025-07-15

Drugs

EvaluationDrugModalityDoseRoute
Comparator Metformin Small molecule 1000 mg Oral

Indications