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IRCT20210622051666N1 IRCT 2023-07-02 Ahvaz University of Medical Sciences Evaluation of oral N-acetylcysteine efficacy versus placebo in prevention of mucositis induced by radiotherapy and chemotherapy agents in children with malignancy Evaluation of oral N-acetylcysteine efficacy versus placebo in prevention of mucositis induced by radiotherapy and chemotherapy agents in children with malignancy A double blind randomized clinical trial 2023-07-23 anticipated 80 Complete https://irct.ir/trial/57383 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Crossover, Purpose: Prevention, Randomization description: In this study, the size of the blocks will be equal. Also, the blinding method will be used to prevent the disclosure of information in each block. Patients entered the study in order of referral. Patients will enter the study according to the order of referral. Patients will be completely randomly divided into two treatment and control groups based on the method of random blocks of six (the sample size of this study is 80). (the length of each block is 4) (the sample size of this study is 80). The randomization sequence will be created using the randomization command in the Excel program (RandomBetween), Blinding description: In this study, the patients are treated with the drug packages predetermined by the study supervisor. The drug packages are totally similar in terms of shape, the patient and the plan administrator are not aware of their contents. In addition, the collection of information, assessment of patients, and completion of forms are done by the project manager and her assistant, who are not aware of the contents of the package. In the stage of data analysis, it will be done by the project manager and only the patient group (Groups 1 and 2) will be determined for data analysis. Therefore, this study is double-blind and from the stage of entering the patient to the completion of the study, data collection, and information analysis, the contents of the two drug groups are not known. 3 CHEMOTHERAPY,MUCOSITIS,RADIATION THERAPY,CANCER. Intervention 1: Intervention group: Patients treated with N-acetylcysteine tablets (200 mg) produced by a pharmaceutical company. The intervention group started the treatment on the first day with a dose of 20-25 mg/kg and with a Maintenance dose of 10 to 15 mg/kg BID will continue for another 14 days. Intervention 2: Control group: patients received placebo tablets, which are similar to N-acetylcysteine tablets (in terms of shape, smell, taste, size, and color) and are made from starch powder with color approved by the pharmacy laboratory of the Faculty of Pharmacy of Ahvaz University of Medical Sciences, for 15 They receive days. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is there is no further information.
public Sepideh Dadfar
Pharmacy faculty , Ahvaz Jundishapur University of Medical Sciences, Golestan St. , Ahvaz , Iran.
Ahvaz Iran (Islamic Republic of) 15794-61357 +98 61 3311 0000 dadfar.s@ajums.ac.ir Ahvaz University of Medical Sciences scientific Farzaneh Hematian
Ahvaz Jundishapur University of Medical Sciences, Golestan St. , Ahvaz , Iran.
Ahvaz Iran (Islamic Republic of) 15794-61357 +98 61 3311 0000 hematian-f@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Patients who are 2-18 years old Recipients of radiotherapy and anti-metabolite chemotherapy drugs with a high risk of developing oral mucositis (including Doxorubicin, Methotrexate, FU Etoposide, Cytarabine and Melphalan) and other drugs listed below. Patients with lansky performance scale index above 70% No Cardiovascular disease 2 years 18 years Both Causes any severe allergic reactions to the drug (such as skin complications, bronchospasm, bronchitis, etc.) Any active gastrointestinal disease Cardiovascular disease K12.31 Oral mucositis (ulcerative) due to antineoplastic therapy Treatment - Drugs Placebo Intervention group: Patients treated with N-acetylcysteine tablets (200 mg) produced by a pharmaceutical company. The intervention group started the treatment on the first day with a dose of 20-25 mg/kg and with a Maintenance dose of 10 to 15 mg/kg BID will continue for another 14 days. Control group: patients received placebo tablets, which are similar to N-acetylcysteine tablets (in terms of shape, smell, taste, size, and color) and are made from starch powder with color approved by the pharmacy laboratory of the Faculty of Pharmacy of Ahvaz University of Medical Sciences, for 15 They receive days. The score of positive and negative symptoms in the PANSS questionnaire. Timepoint: Prevention of mucositis caused by radiotherapy at the beginning of the study (before the start of the intervention) and 7, 15 days after the start of taking N-acetylcysteine. Method of measurement: Questionnaire of positive and negative symptoms of oral mucositis. The level of the oxidative stress factor Malondialdehyde in the blood. Timepoint: Measurement of the oxidative stress factor Malondialdehyde at the beginning of the study (before the start of the intervention) and 7, 15 days after the start of taking N-acetylcysteine. Method of measurement: Measurement of Malondialdehyde oxidative stress factor in patient's blood by UV spectrophotometry. Ahvaz University of Medical Sciences Approved 2022-10-22 Ethics committee of Ahvaz University of Medical Sciences Ahvaz Jundishapur University of Medical Sciences, Golestan St. , Ahvaz , Iran. ahvaz Khouzestan Iran (Islamic Republic of)