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

Tanta University

Status: Completed

Conditions: Colorectal Cancer

Treatments: Drug: Placebo; Drug: Modified FOLFOX-6 regimen; Drug: N-Acetyl Cysteine

Study type: Interventional

Funder types: Other

Identifiers

NCT07391163

36264MS490/1/24

Details and patient eligibility

About

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.

Full 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.

Enrollment: 46 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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46 participants in 2 patient groups, including a placebo group

NAC Group

Experimental group

Description:

Patients receive modified FOLFOX-6 chemotherapy plus oral N-acetyl cysteine 1200 mg administered 1 hour before oxaliplatin throughout chemotherapy cycles.

Treatment:

Drug: N-Acetyl Cysteine

Drug: Modified FOLFOX-6 regimen

Placebo Group

Placebo Comparator group

Description:

Patients receive modified FOLFOX-6 chemotherapy plus oral placebo tablets administered 1 hour before oxaliplatin throughout chemotherapy cycles.

Treatment:

Drug: Modified FOLFOX-6 regimen

Drug: Placebo