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IRCT20090613002027N20 IRCT 2023-04-16 Mazandaran University of Medical Sciences protective effect of N-acetylcysteine on taxane neuropathy Evaluation of the effect of N acetylcysteine on the prevention of peripheral neuropathy induced by taxanes : a randomized double-blind placebo- controlled trial 2023-06-22 anticipated 60 Complete https://irct.ir/trial/67030 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: onsidering the effect of the type of chemotherapy drug on the prevalence and severity of peripheral neuropathy, in order to adjust this intervening factor, stratification was performed based on the received taxane (Paclitaxel or Docetaxel) and randomization to receive acetylcysteine or placebo as It will be done separately in patients receiving paclitaxel and docetaxel. Patients will be placed in two groups, placebo and drug, by Block Balanced Randomization (BBR) method. Using the free web-based system http://www.randomization.com/, the data allocation sequence will be obtained. In this way, the number of subjects in each block is determined to be 4, and the letter A will be used for the control group and the letter B will be used for the test group, and the allocation sequence for 60 samples will be created in 15 blocks of 4 by combining the letters A and B. In order to hide the allocation (Allocation Concealment) using the random number table, a random 4-digit number will be determined as the unique code of each patient so that the grouping status of the patient (A or B) remains hidden. The information about the blocks and the specific code of each patient will be available only to the first operator. The patient, the clinical pharmacy assistant who is in charge of clinical evaluations, and the statistical analyst will not know about the grouping of patients. NAC and placebo drugs will be pre-packaged according to the assigned codes and will be given to the participants after randomization by the clinical pharmacy assistant. Arrangements will be made for all patients to use NAC from a pharmaceutical company, Blinding description: This study will be double blind. In this way, the patient, doctor and clinical assistants will not know about the drug used (N-acetylcysteine or placebo). Medicines and placebos are prepared from a same pharmaceutical company and are provided to patients in similar packages marked with a four-digit code. 2-3 Peripheral neuropathy. 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 drugs in each cycle. Intervention 2: Control group: Effervescent tablets of placebo N-acetylcysteine made by Oswe company 1200 mg one day before and one hour before receiving taxane drugs in each cycle. No - There is not a plan to make this available Justification or reason for not sharing IPD is there is no plan for publishing the protocol of study because it is accessible in IRCT
public Ebrahim salehifar
faculty of pharmacy, payambar azam complex, 18 km farah abad Blvd, khazar square
Sari Iran (Islamic Republic of) 4818893716 +98 11 3354 3083 Esalehifar@mazums.ac.ir Mazandaran University of Medical Sciences scientific ebrahim salehifar
Faculty of pharmacy , Payambar Azam complex, 18 km farah abad blvd, Khazar square
Sari Iran (Islamic Republic of) 4818893716 +98 11 3354 3083 Esalehifar@mazums.ac.ir Mazandaran University of Medical Sciences Iran (Islamic Republic of) 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 18 years no limit Both 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 G63 Polyneuropathy in diseases classified elsewhere Prevention Placebo 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 drugs in each cycle Control group: Effervescent tablets of placebo N-acetylcysteine made by Oswe company 1200 mg one day before and one hour before receiving taxane drugs in each cycle 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. 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. Mazandaran University of Medical Sciences Approved 2023-01-24 Mazandaran Medical University Farah abad Ave, Mazandaran university of Medical Sience Sari Mazandaran Iran (Islamic Republic of)