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IRCT20081202001483N5 IRCT 2022-08-03 Rasht University of Medical Sciences Investigating the effect of probiotics on dry mouth after radiotherapy Comparing the effect of probiotics with placebo on xerostomia in head and neck cancer patients undergoing radiation therapy 2022-09-01 anticipated 82 Complete https://irct.ir/trial/64887 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: A statistician will generate independent allocation sequences and randomisation lists using the Power Analysis & Sample Size (PASS) software. Randomization will be performed in blocks of 4 (2 placebo and 2 probiotic) (21 blocks). To ensure allocation concealment, an independent person will oversee the packaging and labelling of trial treatments based on the randomisation schedule at otorhinolaryngology research center of Guilan University of Medical Sciences (GUMS). Zist Takhmir company (Tehran, Iran) provides the probiotic and placebo; the group assignment list will be withheld until the final evaluation of the study data. All investigators, participants, and outcome assessors will be blinded to the assigned treatment throughout the study, Blinding description: Probiotics and placebo are prepared by Zyst Takhmir and are similar in terms of color, size and dimensions and packages. All the following drugs have a special code and are given to patients by the hospital pharmacist based on the assigned code in the randomization process. Patients and researchers and people who evaluate the results will not know about the type of intervention. 3 Xerostomia. Intervention 1: Intervention group: one probiotic lozenge (Lactogum) before going to bed for 60 days. Intervention 2: Control group: one placebo lozenge before going to bed for 60 days. Yes - There is a plan to make this available What will be shared: In the case of individual patient data, all potential data will be shared after de-identifying individuals. The result of the clinical study will be published in the form of an article. When: The access period starts 6 months after publication of the results. To whom: All researchers Conditions: For secondary data analysis and meta-analysis Where to obtain: Dr Mir Mohammad Jalali Otorhinolaryngology research center, Amiralmomenin HospitalAmiralmomenin Hospital,17 sharivar street, Bank Mell square, Rasht , Iran. 4139638459 Tel: 0098 13 33238306 Mobile: 0098 9111318776 Email: mmjalali@gmail.com How to obtain: After receiving the applicant's request and a brief statement of the protocol in which the mentioned information is used, a preliminary review will be done and the information will be sent to the researcher within 2 weeks. Comments:
public Dr Maryam Akbari
17 sharivar street, Bank Mell square, Amiralmomenin Hospital
Rasht Iran (Islamic Republic of) 4139638459 +98 13 3323 8306 maryamakbari_6699@yahoo.com Rasht University of Medical Sciences scientific Dr Mir Mohammad Jalali
17 Sharivar street, Bank Melli square, Amiralmomenin Hospital
Rasht Iran (Islamic Republic of) 4139638459 +98 13 3323 8306 mmjalali@gmail.com Rasht University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) All head and neck cancer patients who had radiotherapy (after 1-3 months) Functional level equal to or higher than 80 according to the Karnofski criterion Absence of any other oral disease Inability to understand the questionnaire 18 years no limit Both Parkinson disease Sjögren's disease Taking drugs that affect the function of saliva Pregnancy Diabetes Acquired immune deficiency syndrome History of antibiotic use in the last 30 days Use of antifungal drugs or antiseptic mouthwashes K11.7 Disturbances of salivary secretion Treatment - Drugs Placebo Intervention group: one probiotic lozenge (Lactogum) before going to bed for 60 days Control group: one placebo lozenge before going to bed for 60 days Volume of unstimulated saliva. Timepoint: At the beginning of the study (before the start of the intervention), at the end of 2 months and at the end of 3 months. Method of measurement: Measuring the amount of saliva for 5 minutes in unstimulated conditions. Volume of stimulated saliva. Timepoint: At the beginning of the study (before the start of the intervention), at the end of 2 months and at the end of 3 months. Method of measurement: Measuring the amount of saliva for 5 minutes in stimulating conditions (using an applicator dipped in fresh lemon juice). Severity of xerostemia (Visual Analogue Scale; VAS). Timepoint: At the beginning of the study (before the start of the intervention), at the end of 2 months and at the end of 3 months. Method of measurement: The patient chooses a score from 0 (absence of dry mouth) to 10 (worst degree of dry mouth) according to the severity of dry mouth. Score of EORTC QLQ HN43. Timepoint: At the beginning of the study (before the start of the intervention), at the end of 2 months and at the end of 3 months. Method of measurement: using persian version of EORTC QLQ HN43 questionnaire. Rasht University of Medical Sciences Approved 2022-06-27 Ethics committee of Guilan University of Medical Sciences Amiralmomenin Hospital, 17 Sharivar street, Bank Melli Square Rasht Guilan Iran (Islamic Republic of)