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IRCT20161024030467N2 IRCT 2022-01-26 Shahid Beheshti University of Medical Sciences Effects of Sumac spray and Benzydamine Hydrochloride spray on prevention of radiation induced acute mucositis in head and neck cancer Effects of Sumac spray and Benzydamine Hydrochloride spray on prevention of radiation induced acute mucositis in head and neck cancer 2022-02-04 anticipated 44 Complete https://irct.ir/trial/50929 interventional Randomization: Not randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, 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: 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: 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. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
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 dr.ghazalrad@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Head and neck cancer patient Candidate for radiation therapy At least 2 regions of the studied areas in terms of mucositis (based on the mucositis scale) be in the field of radiation therapy Good performance status with ECOG questionnaire between 18 to 80 Willingness to participate in the study Physical and mental ability to cooperate in filling in the questionnaire 18 years 80 years Both Mucositis grade 3 and 4 History of chemotherapy and radiation therapy in mouth or pharynx in recent six months Pregnancy use of artificial saliva use of mouthwashes Candidiasis Having oral herpes alcohol consumption smoking Consumption of drugs affecting salivary glands such as antidepressants, opioids, anti-hypertensives, antihistamines Diuretic use Suffering from diseases of the weakened immune system Dehydration-causing diseases such as chronic diarrhea Diseases that cause recurrent oral plague History of connective tissue diseases such as Sogrene, rheumatoid arthritis, lupus liver and kidney disease major depression diseases involving salivary glands such as diabetes K12.3 Oral mucositis (ulcerative) Placebo Prevention Intervention group: 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: 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 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 2021-08-15 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)