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IRCT20230624058564N1 IRCT 2023-08-06 Tehran University of Medical Sciences Comparing of toll like receptor 2 salivary level in head and neck radiotherapy patients with and without probiotic treatment Comparing of toll like receptor 2 salivary level in head and neck radiotherapy patients with and without probiotic treatment 2023-08-21 anticipated 50 Complete https://irct.ir/trial/70874 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The method of assigning drugs to patients will be randomly and by random permutation blocks with a block size of 4 and 6 changes. The random list will be obtained manually and using the tables in the book "Design and Analysis of Clinical Trials" which is provided under its reference. The random list preparation method will be as follows: In the present study, placebo and probiotic groups (2 groups) were consideredPatients enter the study in order and they are assigned a code according to the order of their entry (codes 1 to 44). To make the first block (for example: a block of size 4), the numbers 1, 2, 3, and 4 are randomized. For example, the order of randomization is 2, 4, 1 and 3, in this case, in the probiotic group, patients with codes 2 and 4 and in the placebo group, patients with codes 1 and 3 are included. To make the second block (for example: a block of size 6), the numbers 5, 6, 7, 8, 9 and 10 are randomized. Suppose the order of randomization is 10, 7, 9, 5, 6 and 8. In this case, in the probiotic group, patients with codes 10, 7, 9 and in the placebo group, patients with codes 5, 6, and 8 are included in the study. This work will be done until all the blocks are obtained and the sample size of 22 people in each group is reachedIn order to conceal the allocation, sealed envelopes are prepared, the contents of which are not known, and envelope numbers 1 to 44 are inserted. Inside each envelope, based on the list of random numbers, the name of the group to which the person will be assigned is mentioned. It should be noted that this step will be performed by a person who has no role in the evaluation of patients. (1) 1. Fleiss JL. Design and analysis of clinical experiments: John Wiley & Sons; 2011, Blinding description: This study will be done in a three-way blind. In this research, the patient, the evaluator (the person who measures the results of the study) and the statistical analyst (dissertation statistics consultant) will be uninformed (blind) of the groups under study. The two drugs used in this research are mouthwashes of the same color with the same smell and temperature, which are placed in containers with the same weight and the same appearance, and are numbered by the pharmacist based on a random list. Each patient who enters the study (in the order of patients' entry) is assigned a code and receives the medicine corresponding to that code. Neither the evaluating dentist nor the patient will know the contents of the packages (because each package has a code and only the manufacturer of the drugs will know the contents of the packages). And the nature of the drugs will be revealed after analyzing the results. 3 Head And Neck Cancer. Intervention group:Intervention group: This group will be given the nutritional counseling that was given to the control group (placebo) for prevention, and in addition, probiotic mouthwash will be prescribed. The way to prepare probiotic mouthwash is to take 3 grams of Femilact powder (femilact zist Takhmir Iran), which contains the composition of probiotic powder containing colony-forming u unit 13.5 x 1010 Lactobacillus acidophilus, Lactobacillus casei, Lactobacillus rhamnosus, Lactobacillus salivarius, Lactobacillus roteri, Bifidobacterium lactis, Bifidobacterium longum and Bifidobacterium debifidom are dissolved in 70 ml of normal saline.They are kept in 70 ml bottles at room temperature and have been checked for physical stability during two months and no changes in their color, smell and aroma have been made. The patient is asked to use the mouthwash three times a day and keep the mouthwash in his mouth for at least 1 to 2 minutes.. 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 I will decide after the end of the study
public Sahar Vaziri
Tehran Farmanieh, Dibaji Shamli Street, Mahmoud Noorian Street, Shahnaz Street, Safa Street, 20 Unit 4
Tehran Iran (Islamic Republic of) 1953643815 +98 21 2615 9477 saharvaziri44@gmail.com Tehran University of Medical Sciences scientific Sahar Vaziri
Tehran Farmanieh, Dibaji Shamli Street, Mahmoud Noorian Street, Shahnaz Street, Safa Street, 20 Unit 4
Tehran Iran (Islamic Republic of) 1953643815 +98 21 2615 9477 saharvaziri44@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Patients with head and neck cancer referred to the Imam Khomeini Hospital Cancer Institute who were diagnosed and operated on the basis of histopathology and are scheduled to undergo IMRT Patients aged 18 years and older 18 years no limit Both 1. Lack of written informed consent to participate in the study 2. Suffering from systemic diseases such as rheumatoid arthritis/hypertension/leukemia/systemic lupus erythromatous and other types of systemic diseases. 3.Having another malignancy and being treated for it 4. Patients who have already received chemotherapy or are undergoing chemotherapy. 5. Pregnant and lactating women Treatment - Drugs Intervention group:Intervention group: This group will be given the nutritional counseling that was given to the control group (placebo) for prevention, and in addition, probiotic mouthwash will be prescribed. The way to prepare probiotic mouthwash is to take 3 grams of Femilact powder (femilact zist Takhmir Iran), which contains the composition of probiotic powder containing colony-forming u unit 13.5 x 1010 Lactobacillus acidophilus, Lactobacillus casei, Lactobacillus rhamnosus, Lactobacillus salivarius, Lactobacillus roteri, Bifidobacterium lactis, Bifidobacterium longum and Bifidobacterium debifidom are dissolved in 70 ml of normal saline.They are kept in 70 ml bottles at room temperature and have been checked for physical stability during two months and no changes in their color, smell and aroma have been made. The patient is asked to use the mouthwash three times a day and keep the mouthwash in his mouth for at least 1 to 2 minutes. Toll like receptor 2. Timepoint: The expression level of Toll like receptor 2 is measured by ELISA method at two basic times (once before the start of treatment and once after the completion of radiotherapy treatment) and after the completion of radiotherapy treatment. Method of measurement: Toll like receptor 2 is performed through ELISA test kit and saliva test. The percentage of people who get grade 2 oral mucositis. Timepoint: They will be checked for oral mucositis once every three days, and the condition of oral mucositis will be recorded and if it is, its grade will be recorded. Method of measurement: Based on the amount of oral ulcers, it is examined and recorded by a specialist in oral and dental diseases. Tehran University of Medical Sciences Approved 2022-09-04 Ethics Committee in Research Faculty of Dentistry - Tehran University of Medical Sciences Farmanieh, Dibaji Shamli Street, Mahmoud Noorian Street, Shahnaz Street, Safa Street, 20 Unit 4 Tehran Tehran Iran (Islamic Republic of)