Evaluation of the effect of N acetylcysteine on the prevention of peripheral neuropathy induced by taxanes : a randomized double-blind placebo- controlled trial

Evaluation of the protective effect of N-acetylcysteine in peripheral neuropathy caused by chemotherapy with taxanes

A Clinical trial with two parallel groups, with a control group, with placebo, double-blind, phase 3, with a sample size of 60 people. Randomization with the help of Excel software and quadruple blocks.

In order to investigate the preventive effect of N-acetylcysteine in peripheral neuropathy caused by taxanes in patients receiving AC-T regimen in Imam Khomeini Hospital, Sari. This study has two arms of medicine and placebo, and a four-digit code is assigned to each patient through the Excel program.

Inclusion criteria: Patients who are candidates for AC-T regimen, over 18 years of age, with normal baseline bone marrow, liver, kidney, and heart function. Exclusion criteria: Patients with a previous history of neurological diseases, neuropathic pain, renal clearance above 30, severe liver failure, heavy alcohol and opioid users, pregnant and lactating women, uncontrolled diabetes.

intervention group: N-Acetylcysteine (NAC) Effervescent Tablets, 1200 mg, 24 hours before chemotherapy and on the day of chemotherapy, one hour before receiving taxane in each cycle Control group: Placebo NAC effervescent tablet 1200 mg one day before and one hour before receiving taxane in each cycle

severity of peripheral neuropathy; pain intensity; Quality of Life ; Serum level of oxidative factors

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.

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.

there is no plan for publishing the protocol of study because it is accessible in IRCT

All data are shareable after publishing

Start the access period 6 months after publishing the result

All researchers

for used in clinical practice and also future meta-analysis

Ebrahim Salehifar / Emai: Esalehifar52@gmail.com

sending email to Dr Ebrahim Salehifar