Peripheral neuropathy. Polyneuropathy in diseases classified elsewhere
Conditions
Interventions
Intervention 1: Intervention group: Acetylcysteine effervescent tablets made by Oswe company, 1200 mg 24 hours before chemotherapy and on the day of chemotherapy, one hour before receiving taxane drug
Sponsors
Mazandaran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactEbrahim salehifar
Mazandaran University of Medical Sciences
Outcome results
None listed