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IRCT20190810044500N9 IRCT 2021-01-09 Yazd University of Medical Sciences Effectiveness of timolol mouthwash to prevention chemotherapy-induced mucositis Randomized clinical trial of the effectiveness of timolol mouthwash to prevention chemotherapy-induced mucositis 2020-10-09 anticipated 30 Complete https://irct.ir/trial/46768 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patients were randomly assigned to two groups of 15 controls or intervention by permutation block method. Treatment assignments within blocks are determined so that they are random in order but that the desired allocation proportions are achieved exactly within each block. 7 blocks of 4 and a block of two are considered. Generation of random codes using Permuted Block Randomization method will be done with the help of Random allocation software (version 1). The first person who is eligible to enter the study is given number one and likewise the last eligible person is given number 30. By using the software generated table, patients receive each of intervention (A or B). In order to consider blinding in random allocation, the list is given to another person outside the study and using short message service (SMS) before assigning the type of treatment according to the number of eligible people is asked and thus people enter the study, Blinding description: The steps will be covered from the perspective of the patient, the treating physician and the assessors. The first presenter identifies the sequence of assignment of patients according to the order of entry of the patients into the study, and puts the mouthwashes into one-size boxes for patient use and identifies them with A or B codes. The student then delivers the drugs to each individual patient. 2 Chemotherapy-induced mucositis. Intervention 1: Intervention group: patients will take timolol 0.5% in combination with hyaluronic acid 0.25% and xylitol 0.75% mouthwash three times a day for six weeks. Intervention 2: Control group: patients will take placebo mouthwash three times a day for six weeks.placebo contains hyaluronic acid 0.25% and xylitol 0.75%. 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 Fatemeh Saghafi
Professor Hesabi Blvd., Yazd Province, Yazd, Iran
Yazd Iran (Islamic Republic of) 8915173143 +98 35 3820 3419 F.saghafi@ssu.ac.ir Yazd University of Medical Sciences scientific Fatemeh Saghafi
Professor Hesabi Blvd, Yazd Province, Yazd, Iran
Yazd Iran (Islamic Republic of) 8915173149 +98 35 3820 3419 F.saghafi@ssu.ac.ir Yazd University of Medical Sciences Iran (Islamic Republic of) All patients over 18 years of age undergo chemotherapy Adequate literacy to fill out a consent form, understand the study, use the drug, report pain and possible side effects 18 years no limit Both Intolerance to medication, misuse of mouthwash People with a history of bradycardia Z51.11 Encounter for antineoplastic chemotherapy Prevention Placebo Intervention group: patients will take timolol 0.5% in combination with hyaluronic acid 0.25% and xylitol 0.75% mouthwash three times a day for six weeks. Control group: patients will take placebo mouthwash three times a day for six weeks.placebo contains hyaluronic acid 0.25% and xylitol 0.75%. Clinical presentation. Timepoint: Before starting chemotherapy, after starting chemotherapy every week and finally one week after the end of mouthwash consumption (8 visits in total). Method of measurement: Oral examination. The severity of mucositis. Timepoint: Before starting chemotherapy, after starting chemotherapy every week and finally one week after the end of mouthwash consumption (8 visits in total). Method of measurement: Oral examination and checklists for WHO in 5 grades. The severity of the pain. Timepoint: Before starting chemotherapy, after starting chemotherapy every week and finally one week after the end of mouthwash consumption (8 visits in total). Method of measurement: Oral examination based on the VAS index. Quality of life. Timepoint: End of the study. Method of measurement: According to the questionnaire EORTC QLQ-C30 (version 3). Complications observed. Timepoint: End of the study. Method of measurement: Based on the doctor's observation and the person's statements. Yazd University of Medical Sciences Approved 2020-09-13 Ethics Commitee of Shahid Sadoughi University Medical Sciencrs Proferssor Hesabi Blvd, Yazd Yazd Yazd Iran (Islamic Republic of)