N-acetyl Cysteine Effect in Peripheral Neuropathy in Cancer Patients

• Status: Completed
• Trial end date: 2019-06-30
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to evaluate the effect of N-acetyl cysteine in combination with paclitaxel on the clinical outcomes of patients with peripheral neuropathy, paclitaxel-induced peripheral neuropathy affect quality of life in cancer patients.

new therapeutic approches such as the antioxidant N-acetyl cysteine, showed to has neuroprotective effect, the aim of the study is to evaluate the effect of N- acetylcysteine(NAC) administration in the prevention of paclitaxel-Induced peripheral neuropathy.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ain Shams University
• Collaborator: Nasser Institute For Research and Treatment
• Treatments: Acetylcysteine; Albumin-Bound Paclitaxel; N-monoacetylcystine; Paclitaxel

Criteria

Inclusion Criteria:

1. Adult patients (>18 years old).

2. Breast cancer patients who will receive adjuvant weekly paclitaxel for 12 cycles.

3. ECOG performance status 0-2

4. Adequate bone marrow function (white blood count ≥4,000/mm3, platelet count ≥100,000/mm3), liver function (serum total bilirubin <1.5 mg/dl), renal function (creatinine <1.5 mg/dl).

Exclusion Criteria:

1. Patients who have any of the following:

• Clinical neuropathy.

• Diabetes mellitus.

2. Patients receiving vitamin B1, B6, B12,or other vitamin supplemental therapy.

3. Patients receiving antidepressants, opioids, adjuvant analgesic agents (eg, anticonvulsants, clonazepam, or mexiletine), topical analgesics, and amifostine.

4. Hypersensitivity to NAC.