Clinical trial · Interventional
Protective Effect of N-acetylcysteine on Oxaliplatin-Induced Neuropathy in Colorectal Cancer
The Possible Protective Role of N-Acetylcysteine Against Oxaliplatin-Induced Peripheral Neuropathy in Patients With Colorectal Cancer
NCT07391163CI-TRIAL-00102896completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
This study investigates the possible protective role of N-Acetylcysteine against oxaliplatin-induced peripheral neuropathy in patients with colorectal cancer. The trial aims to evaluate whether N-Acetylcysteine can reduce the incidence and severity of neuropathy during chemotherapy.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Modified FOLFOX-6 regimen | Drug | — | UNRESOLVED |
| N-Acetyl Cysteine | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- NAC Group
- description
- Patients receive modified FOLFOX-6 chemotherapy plus oral N-acetyl cysteine 1200 mg administered 1 hour before oxaliplatin throughout chemotherapy cycles.
- interventionNames
- Drug: N-Acetyl Cysteine
- Drug: Modified FOLFOX-6 regimen
- type
- PLACEBO_COMPARATOR
- label
- Placebo Group
- description
- Patients receive modified FOLFOX-6 chemotherapy plus oral placebo tablets administered 1 hour before oxaliplatin throughout chemotherapy cycles.
- interventionNames
- Drug: Placebo
- Drug: Modified FOLFOX-6 regimen
Primary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Males and females aged ≥ 18 years old. * Patients with histologically confirmed diagnosis of Stage III colorectal cancer and high risk Stage II. * Patients who will be scheduled to receive modified FOLFOX-6. * Patients with no contraindication to chemotherapy. * Adequate baseline hematologic values (absolute neutrophilic count ≥ 1.5 * 109/L, platelet count ≥ 100 × 109/L and hemoglobin level ≥ 10 g/dl). * Patients with adequate renal function (serum creatinine \< 1.5 mg/dl or creatinine clearance (ClCr) ˃ 45 mL/min). * Patients with adequate liver function (serum bilirubin \< 1.5 mg/dl). * Patients with performance status 0-1 according to Eastern Cooperative Oncology Group (ECOG) score. Exclusion Criteria: * Children \< 18 years old. * Prior exposure to chemotherapy. * Patients with diabetes and other conditions that predispose to neuropathy. * History of known allergy to oxaliplatin or other platinum agents. * Concomitant use of any drug has anti-oxidant activity or neuroprotective agent. * Patients take any medication that increase acetyle choline either central or peripheral. * Patient was any cardiac disease. * Pregnant and breastfeeding women.
References
Publications (4)
- BACKGROUNDStarobova H, Vetter I. Pathophysiology of Chemotherapy-Induced Peripheral Neuropathy. Front Mol Neurosci. 2017 May 31;10:174. doi: 10.3389/fnmol.2017.00174. eCollection 2017. PMID 28620280
- BACKGROUNDTardiolo G, Bramanti P, Mazzon E. Overview on the Effects of N-Acetylcysteine in Neurodegenerative Diseases. Molecules. 2018 Dec 13;23(12):3305. doi: 10.3390/molecules23123305. PMID 30551603
- BACKGROUNDBaidoun F, Elshiwy K, Elkeraie Y, Merjaneh Z, Khoudari G, Sarmini MT, Gad M, Al-Husseini M, Saad A. Colorectal Cancer Epidemiology: Recent Trends and Impact on Outcomes. Curr Drug Targets. 2021;22(9):998-1009. doi: 10.2174/1389450121999201117115717. PMID 33208072
- BACKGROUNDTardiolo G, Bramanti P, Mazzon E. Migraine: Experimental Models and Novel Therapeutic Approaches. Int J Mol Sci. 2019 Jun 15;20(12):2932. doi: 10.3390/ijms20122932. PMID 31208068