NCT05921942

The Impact of Metformin Administration on the Clinical Outcome of Stage IV Colon Cancer

Completed Phase 3 Last updated 2 February 2024

What this trial tests

Phase 3 trial testing Metformin in Colorectal Cancer in 70 participants. Completed in 30 December 2022.

Timeline

15 April 2020

Primary endpoint
30 December 2022

30 December 2022

Quick facts

Lead sponsor	Ain Shams University
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	70
Start date	15 April 2020
Primary completion	30 December 2022
Estimated completion	30 December 2022
Sites	1 location across Egypt

Drugs / interventions tested

• Metformin (metformin) — full drug profile →

Conditions studied

• Colorectal Cancer — all drugs for Colorectal Cancer →

Sponsor

Ain Shams University

Who can join

Adults 18 to 65, any sex, with Colorectal Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Design: Prospective, randomized controlled trial Setting: Clinical Oncology and Nuclear Medicine, Ain Shams University Condition: Colorectal cancer

Patients will be randomized into one of two groups:

Group A: Patients will receive standard therapy FOLFOX PROTOCOL Group B: Patients will receive metformin (500 mg twice daily or 1000 mg once daily) on top of standard therapy

Assessment:

Baseline Assessment:

* Patient Full History: Age, sex, smoking history, occupational history, medical history, concurrent diseases and medications.
* Laboratory data:
* Complete blood test
* Liver functional test
* Renal function test
* Inflammatory Markers: Interleukin (IL)-6

EVERY 3 MONTH: CT/MRI /PET scan to detect the response to chemotherapy and progression , Quality of life by European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30. (EORTC QLQC30), Assessment of chemotherapy toxicity using CTACE 4.0 .

Every 2 CYCLE: Lab examination (CBC, Liver function, Kidney function),CTACE SIDE EFFECTS EXAMINATION AFTER 6 MONTH : iL-6 LEVELS AFTER 1 YEAR : PFS AND OS

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Metformin-based nanomedicines for reprogramming tumor immune microenvironment.
   Liu J, Li X, Li Y, Gong Q, et al · · 2025 · cited 72× · PMID 39776799 · DOI 10.7150/thno.104872
2. Systematic and comprehensive insights into HIF-1 stabilization under normoxic conditions: implications for cellular adaptation and therapeutic strategies in cancer.
   Zhang J, Yao M, Xia S, Zeng F, et al · · 2025 · cited 63× · PMID 39757165 · DOI 10.1186/s11658-024-00682-7
3. Metformin: A Dual-Role Player in Cancer Treatment and Prevention.
   Galal MA, Al-Rimawi M, Hajeer A, Dahman H, et al · · 2024 · cited 44× · PMID 38612893 · DOI 10.3390/ijms25074083
4. Epithelial-mesenchymal transition in colorectal cancer metastasis and progression: molecular mechanisms and therapeutic strategies.
   Nie F, Sun X, Sun J, Zhang J, et al · · 2025 · cited 27× · PMID 40695791 · DOI 10.1038/s41420-025-02593-8
5. Drug Repurposing for Cancer Treatment: A Comprehensive Review.
   Al Khzem AH, Gomaa MS, Alturki MS, Tawfeeq N, et al · · 2024 · cited 24× · PMID 39596504 · DOI 10.3390/ijms252212441
6. Immunometabolism: crosstalk with tumor metabolism and implications for cancer immunotherapy.
   Zhang H, Fan J, Kong D, Sun Y, et al · · 2025 · cited 8× · PMID 41063213 · DOI 10.1186/s12943-025-02460-1
7. The synergistic potential of mechanotherapy and sonopermeation to enhance cancer treatment effectiveness.
   Neophytou C, Stylianopoulos T, Mpekris F. · · 2025 · cited 6× · PMID 40337117 · DOI 10.1038/s44341-025-00017-3
8. Current trends and future prospects of drug repositioning in gastrointestinal oncology.
   Fatemi N, Karimpour M, Bahrami H, Zali MR, et al · · 2023 · cited 4× · PMID 38239190 · DOI 10.3389/fphar.2023.1329244