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IRCT20161024030467N1 IRCT 2019-05-12 Shahid Beheshti University of Medical Sciences Effects of mucutin spray and Benzydamine Hydrochloride spray on prevention of radiation induced acute mucositis in head and neck cancer patients Effects of mucutin spray and Benzydamine Hydrochloride spray on prevention of radiation induced acute mucositis in head and neck cancer patients: A comparative clinical study 2019-09-01 anticipated 44 Complete https://irct.ir/trial/36269 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Simple randomization is done by Randomizer software, before starting the trial. Patients who have inclusion criteria, are randomly assigned into one of the two groups based on their selected number: mucutin spray or Benzydamine Hydrochloride spray. The two groups of the trial according to a previous studies and by taking into account two-sided significance level of 0.05 and power of 99%, the sample size is calculated 20 patients in each group. Considering the possibility of failure to follow up and patients’ drop out, in order to increase the power of the study, the sample size is calculated 22 patients in each group to be totally 44 patients, Blinding description: Firstly, the protocol would be described to the participants. Then, they will sign written informed consent to start the trial. The investigator is not aware of Groups allocation and will examine and record the patients findings. 3 Oral mucositis. Intervention 1: Intervention group 1: Mucutin spray group who use the spray 4-8 times per day from a day before the start of radiotherapy up to two weeks of end of radiotherapy or until leaving the study for any reason. Intervention 2: Intervention group 2: benzydamine hydrochloride spray group who use the spray 4-8 times per day from a day before the start of radiotherapy up to two weeks of end of radiotherapy or until leaving the study for any reason. Yes - There is a plan to make this available What will be shared: Demographic data and the result of the clinical trial When: after 6 month To whom: researchers Conditions: After publishing a monochrome article from a clinical trial Where to obtain: send to researchers How to obtain: Send request via email Comments:
public Dr. Ghazaleh Heydarirad
No. 8, Shams street, Valiasr street.
tehran Iran (Islamic Republic of) 1516745811 +98 21 8877 6027 ghazalrad@yahoo.com Shahid Beheshti University of Medical Sciences scientific Dr. Ghazaleh Heydarirad
No 8, shams street, Valiasr street
Tehran Iran (Islamic Republic of) 1516745811 +98 21 8877 6027 ghazalrad@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Head and neck cancer and radiotherapy candidate age between 18 to 80 Life expectancy more than a year based on physician or team estimates Physical and mental ability to cooperate in filling in the questionnaire desire to participate in the study Good performance status with ECOG questionnaire At least 2 regions of the studied areas in terms of mucositis (based on the mucositis scale) be in the field of radiation therapy 18 years 80 years Both Use of alcohol, drugs that affect salivary glands such as antipsychotics, opioids, antihypertensives, antihistanines, diuretics, mouthwashes and artificial saliva and cigarettes history of radiation therapy and chemotherapy in mouth or pharynx in recent six months history of connective tissue diseases such as Sogrene, rheumatoid arthritis, lupus; liver and kidney disease; major depression; diseases involving salivary glands such as diabetes; diseases causing dehydration such as chronic diarrhea, immune deficiency disorders, myelosuppression, diseases causing repeated oral aphthous Mucositis grade 3 and 4 Candidosis or oral herpes Pregnancy K12.3 Oral mucositis (ulcerative) Prevention Prevention Intervention group 1: Mucutin spray group who use the spray 4-8 times per day from a day before the start of radiotherapy up to two weeks of end of radiotherapy or until leaving the study for any reason. Intervention group 2: benzydamine hydrochloride spray group who use the spray 4-8 times per day from a day before the start of radiotherapy up to two weeks of end of radiotherapy or until leaving the study for any reason. Mucositis. Timepoint: At the baseline, Weeks 1,2,3,4,5,6,7. Method of measurement: Examination of oral cavity. Shahid Beheshti University of Medical Sciences Approved 2018-07-30 Ethics Committee on Biomedical Research of Shahid Beheshti University of Medical sciences Shahid Beheshti University of Medical Sciences, next to Taleghani Hospital, Parvaneh St., Yemen St., Shahid Chamran Highway. Tehran Tehran Iran (Islamic Republic of)