NCT06728982

Impact Of Metformin In Rectal Cancer Patients

Metformin Enhances Pathological Complete Response in Non-Diabetic Rectal Cancer Patients Undergoing Neoadjuvant Chemoradiotherapy: A Randomized Controlled Trial

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: Minia University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rectal Cancer Patients

Interventions

Type	Name	Description
DRUG	Metformin	1000mg of metformin twice daily by mouth

Timeline

• Start date: 2024-05-01
• Primary completion: 2025-06-15
• Completion: 2025-07-15
• First posted: 2024-12-11
• Last updated: 2025-08-01

Locations

2 sites across 1 country: Egypt