NCT07391163

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Tanta University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Oxaliplatin, a common chemotherapeutic agent for colorectal cancer, often induces peripheral neuropathy, which can significantly affect patients' quality of life and limit treatment effectiveness. The neuropathy is partly caused by nerve inflammation and oxidative stress. N-Acetylcysteine (NAC), an antioxidant, has been suggested to protect neurons from oxidative damage and reduce inflammation. This interventional, randomized, parallel-assignment study will enroll colorectal cancer patients receiving oxaliplatin-based chemotherapy. Participants will be assigned to either receive N-Acetylcysteine alongside chemotherapy or chemotherapy alone. Primary outcomes include the incidence and severity of peripheral neuropathy measured at predefined intervals during treatment. Secondary outcomes include biochemical markers of nerve inflammation and oxidative stress, including: * Neurotensin (marker of nerve inflammation) * Interleukin-6 (marker of systemic inflammation) * Total Antioxidant Capacity (marker of oxidative stress) The study aims to provide evidence on whether N-Acetylcysteine can serve as a protective agent against chemotherapy-induced neuropathy, potentially improving treatment tolerance and patient outcomes.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Placebo	Oral placebo tablets identical in appearance to N-acetyl cysteine, administered 1 hour before oxaliplatin throughout chemotherapy cycles.
DRUG	N-Acetyl Cysteine	Oral N-acetyl cysteine 1200 mg administered 1 hour before oxaliplatin throughout chemotherapy cycles.
DRUG	Modified FOLFOX-6 regimen	Oxaliplatin 85 mg/m² IV, leucovorin 400 mg/m² IV, followed by 5-fluorouracil bolus and continuous infusion every 2 weeks.

Timeline

• Start date: 2024-01-01
• Primary completion: 2026-01-01
• Completion: 2026-01-01
• First posted: 2026-02-05
• Last updated: 2026-02-10

Locations

1 site across 1 country: Egypt