protective effect of N-acetylcysteine on taxane neuropathy

Phase 2

Conditions: Peripheral neuropathy.
Polyneuropathy in diseases classified elsewhere

Registration Number: IRCT20090613002027N20

Lead Sponsor: Mazandaran University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 60

Inclusion Criteria

AC-T regimen recipient
People over 18 years old
For normal bone marrow function (ANC>1500/mm3 and Plt>100000//mm3)
Having normal liver function (bili<1.5 mg/dl - liver enzymes level less than three times the maximum normal range) and normal kidney function (cr<1.5 mg/dl)
Normal baseline ECG

Exclusion Criteria

Patients with previous history of neurological diseases such as hereditary and acquired neuropathies
Patients with neuropathic pain due to conditions such as postherpetic neuralgia, uncontrolled diabetes with neuropathy, trigeminal neuralgia, spinal cord injury or other neurological diseases, known vitamin B12 deficiency, amyloidosis, neuromuscular diseases and connective tissue diseases.
Creatinine clearance less than 30 ml/min
Severe liver failure (liver enzymes more than three times the normal limit)
History of allergy and sensitivity to N-acetylcysteine
Uncontrolled diabetes
Alcoholic patients
chronic use of vitamin B1 and supplements containing magnesium
Taking antiepileptic drugs
Use of opioids
Pregnant or lactating women
Lack of consent to participate in the study

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Severity of neuropathy. Timepoint: At the beginning of the study, the end of the 4th cycle and one month after the end of the drug regimen. Method of measurement: based on NCI CTCAE version 5 , FACT/GOG-Ntx , Neuropathy pain scale.;Intensity of pain. Timepoint: At the beginning of the study, the end of the 4th cycle and one month after the end of the drug regimen. Method of measurement: based on Numeric pain rating scale.

Secondary Outcome Measures

Name	Time	Method
Quality of life. Timepoint: At the beginning of the study, the end of the 4th cycle and one month after the end of the drug regimen. Method of measurement: based on EORTC QLQ-C30 version 3.;Serum level of glutathione. Timepoint: At the beginning of the study and at the end of 4th cycle. Method of measurement: blood sample.;Serum level of capacity of antioxidant enzymes. Timepoint: At the beginning of the study and at the end of 4th cycle. Method of measurement: blood sample.;Serum level of lipid peroxidation. Timepoint: At the beginning of the study and at the end of 4th cycle. Method of measurement: blood sample.;Level of nitric oxide. Timepoint: At the beginning of the study and at the end of 4th cycle. Method of measurement: blood sample.