Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer Patients | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Metformin | Drug | Metformin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Group A
- description
- Patients will receive standard chemoradiotherapy(CRT)
- type
- ACTIVE_COMPARATOR
- label
- Group B (Metformin)
- description
- 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.
- interventionNames
- Drug: Metformin
Primary outcomes (1)
- measure
- Pathological Complete Response (pCR) rate
- timeFrame
- 6 months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDAwad OM, Saber MA, Ali Sholkamy NH, Abdel-Azeez AM, Sadek EM, Mady FM. Metformin enhances the pathological response in nondiabetic patients with rectal cancer undergoing neoadjuvant chemoradiotherapy: A randomized controlled trial. J Pharmacol Exp Ther. 2026 Jun 19;393(8):104970. doi: 10.1016/j.jpet.2026.104970. Online ahead of print. PMID 42456199