Clinical trial · Interventional
The Impact of Metformin Administration on the Clinical Outcome of Stage IV Colon Cancer
- 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 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
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 |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
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 therapy FOLFOX/XELOX PROTOCOL
- type
- ACTIVE_COMPARATOR
- label
- Group B
- description
- Patients will receive metformin (500 mg twice daily or 1000 mg once daily) in addition to standard therapy FOLFOX/XELOX PROTOCOL
- interventionNames
- Drug: Metformin
Primary outcomes (2)
- measure
- Disease Control Rate according to Response evaluation criteria in solid tumors ( RECIST) 1.1
- timeFrame
- 6 months
- description
- defined as tumor response of patients in Complete remission, partial remission or stable disease from randomization of first subject until database cutoff at 6 month interval
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: A- •Patients above 18 years old and above B- •Patients who approved to be enrolled in study by documented consent C- Patients with metastatic colon cancer D- NON -Diabetic patients E- Patients with satisfactory hematological and biochemical functions defined as: I. Platelets (Plts) \>100 x 10\^9 II. Creatinine Clearance (Crcl) \>60 ml/min or \>45-59 but receive single dose of medication III. Aspartate Aminotransferase (AST) AND Alanine Aminotransferases (ALT) \<2.5 ULN IV. Absolute Neutrophilic count (ANC) \>1,500 / mm\^3 V. Eastern Cooperative Oncology Group (ECOG) performance 0-2 Exclusion Criteria: * Patients with hypersensitivity to metformin, renal or hepatic impairment that may predispose lactic acidosis * Patients with previous or current severe breathing problems (as obstructive lung disease, severe asthma) or dehydration
References
Publications (0)
Data not yet available