Randomized clinical trial of the effectiveness of timolol mouthwash to prevention chemotherapy-induced mucositis

Determining the effect of thymolol mouthwash in the prevention of oral mucositis caused by chemotherapy

Patients in two groups receiving Timolol 5% mouthwash or placebo will be randomly divided into reciprocating blocks (each group of 15 people) and each patient will use mouthwashes belonging to their group 3 times a day for 6 weeks. Patients will not use other therapies during this time. This is a forward-looking, two-way blind study of randomized controlled clinical trial and will be performed on 30 patients who accidentally enter two groups of 15 people to control or intervention.

Patients admitted to the study will be selected from the clients of the chemotherapy department of Shahid Sadoughi Hospital in Yazd and will enter the study at random.

Conditions for entering the study: all patients over 18 years of age who are being treated with chemotherapy. Adequate literacy to fill the consent form, comprehension study, drug use, pain reporting and possible side effects. Conditions for leaving the study: intolerance to medication; not using mouthwash properly. People with a history of bradycardia.

They receive a 5% thymol oral mouthwash and a placebo mouthwash control group

Clinical presentation; intensity of mucositis and intensity of pain

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.

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