Impact Of Metformin In Rectal Cancer Patients

July 29, 2025 updated by: Omar Mohamed Awad, Minia University

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

85

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Minya, Egypt, 61512
        • Minia Oncology Center
      • Minya, Egypt, 61512
        • Minia University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Group A
Patients will receive standard chemoradiotherapy(CRT)
Active Comparator: Group B (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.
Drug: Metformin
1000mg of metformin twice daily by mouth

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pathological Complete Response (pCR) rate
Time Frame: 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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Minia University

Investigators

  • Principal Investigator: Omar M Awad, Bsc, Deraya university
  • Study Chair: Fatma M Mady, professor, Minia university
  • Study Director: Mona A Saber, PhD, Minia university

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2024

Primary Completion (Actual)

June 15, 2025

Study Completion (Actual)

July 15, 2025

Study Registration Dates

First Submitted

November 29, 2024

First Submitted That Met QC Criteria

December 6, 2024

First Posted (Actual)

December 11, 2024

Study Record Updates

Last Update Posted (Actual)

August 1, 2025

Last Update Submitted That Met QC Criteria

July 29, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Metformin In Rectal Cancer

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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