Impact Of Metformin In Rectal Cancer Patients

NCT06728982 | Completed Phase 2 DMC

• 1 other identifier: Metformin In Rectal Cancer
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 2

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. 1.Histologically confirmed diagnosis of rectal adenocarcinoma.
2. 2.Age starting from 18 and older.
3. 3.Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
4. 4.Adequate organ function (renal, hepatic, and hematological)
5. 5.Signed informed consent.
6. 6.beginning 1-2 weeks before standard CRT.
7. 7.during standard CRT.
8. 8.until 30 days after the end of standard CRT.

Conditions

Rectal Cancer Patients

Keywords

metformin; complete pathological response; rectal patient; neoadjuvant chemoradiotherapy

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Study Arms (2)

Group A

NO INTERVENTION

Patients will receive standard chemoradiotherapy(CRT)

Group B (Metformin)

ACTIVE COMPARATOR

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.

Drug: Metformin

Interventions

Metformin DRUG

1000mg of metformin twice daily by mouth

Group B (Metformin)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed diagnosis of rectal adenocarcinoma.
• Age starting from 18 and older.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
• Adequate organ function (renal, hepatic, and hematological)
• Signed informed consent.

You may not qualify if:

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

Sponsors & Collaborators

• Minia University: lead

Study Sites (2)

Minia Oncology Center

Minya, Egypt, 61512, Egypt

Location

Minia University Hospital

Minya, Egypt, 61512, Egypt

Location

MeSH Terms

Conditions

Pathologic Complete Response

Interventions

Metformin

Condition Hierarchy (Ancestors)

Disease Progression; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Omar M Awad, Bsc

  Deraya University

  PRINCIPAL INVESTIGATOR

• Fatma M Mady, professor

  Minia University

  STUDY CHAIR

• Mona A Saber, PhD

  Minia University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching Assistant

Model Details: 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 Record Dates

• First Submitted: November 29, 2024
• First Posted: December 11, 2024
• Study Start: May 1, 2024
• Primary Completion: June 15, 2025
• Study Completion: July 15, 2025
• Last Updated: August 1, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)