Using Metformin for Rectal Cancer Treatment
Impact of Metformin on Complete Pathological Response in Rectal Cancer Patients Receiving Neoadjuvant Concurrent Chemoradiotherapy
This study is testing if adding metformin to standard treatment can help adults with rectal cancer get better results from their therapy.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 85 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Minia University Academic / other |
| Locations | 2 sites (Minya and 1 other locations) |
| Trial ID | NCT06728982 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of metformin on patients with rectal adenocarcinoma undergoing standard chemoradiotherapy. Participants will be randomly assigned to receive either standard treatment or metformin alongside their therapy. The trial aims to assess the potential for metformin to enhance treatment outcomes, specifically focusing on complete pathological response. Eligible patients must be adults with confirmed rectal cancer and adequate organ function.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of rectal adenocarcinoma and an ECOG performance status of 0-2.
Not a fit: Patients with metastatic disease, contraindications to metformin, or significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment outcomes for rectal cancer patients by enhancing the effectiveness of chemoradiotherapy.
How similar studies have performed: While the use of metformin in cancer treatment is being explored, this specific approach in rectal cancer is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Minya and 1 other locations
- Minia Oncology Center — Minya, Egypt (Recruiting)
- Minia University Hospital — Minya, Egypt (Recruiting)
Study contacts
- Principal investigator: Omar M Awad, Bsc — Deraya University
- Study coordinator: Omar M Awad, Bsc
- Email: omr.awad@deraya.edu.eg
- Phone: +201017646626
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.