CompletedNot Applicable

Protective Effect of N-acetylcysteine on Oxaliplatin-Induced Neuropathy in Colorectal Cancer

Egypt46 participantsStarted 2024-01-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

NCI-CTCAE, Version 5, 2017

Timeframe: Adverse events will be assessed using NCI-CTCAE v5.0 at baseline (Day 1, prior to Cycle 1) and after Cycle 2 (Day 15) and after Cycle 4 (Day 29). Each chemotherapy cycle lasts 14 days.

FACT/GOG-Ntx-12

Timeframe: Neurotoxicity-related adverse events will be assessed using the FACT/GOG-Ntx-12 at baseline (Day 1, prior to Cycle 1) and after Cycle 2 (Day 15) and after Cycle 4 (Day 29). Each chemotherapy cycle lasts 14 days.

BPI-SF

Timeframe: Pain severity and interference will be assessed using the BPI-SF at baseline (Day 1, prior to Cycle 1) and after Cycle 2 (Day 15) and after Cycle 4 (Day 29). Each chemotherapy cycle lasts 14 days.

Trial details

NCT IDNCT07391163

SponsorTanta University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-01-01

View on ClinicalTrials.gov More Colorectal Cancer trials