Impact Of Metformin In Rectal Cancer Patients

Phase 1

Recruiting

• Conditions: Rectal Cancer Patients
• Interventions: Drug: Metformin

• Registration Number: NCT06728982
• Lead Sponsor: Minia University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-29
• Study Start: 2024-12-01
• Study First Submitted QC: 2024-12-06
• Study First Posted: 2024-12-11
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-09
• Last Update Posted: 2025-05-11
• Primary Completion: 2025-11
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 85

Inclusion 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.

Exclusion Criteria

1. Metastatic disease.
2. Contraindications to metformin.
3. Significant comorbidities or medical conditions that may interfere with study participation. (D.M, PCO,..)
4. eGFR less than 30 mL/min.
5. Pregnant or breastfeeding women.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B (Metformin)	Metformin	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.

Primary Outcome Measures

Name	Time	Method
Pathological Complete Response (pCR) rate	6 months	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.

Trial Locations

Locations (2)

Minia Oncology Center; 🇪🇬 Minya, Egypt

Minia University Hospital; 🇪🇬 Minya, Egypt