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IRCT20190511043551N1 IRCT 2019-10-16 Shiraz University of Medical Sciences Mucosamin in treatment of oral cavity mucositis Evaluation of the effect of Mucosamin in treatment of radiation induced oral cavity mucositis during and after radiotherapy، in patient with oral cavity squamous cell carcinoma (SCC) 2019-10-02 anticipated 80 Complete https://irct.ir/trial/40979 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this trial, subjects will be randomly assigned to one of two intervention and control groups using the random number table. There are no prerequisites for assigning individuals to groups. The randomization unit is individual. Each participant will have an equal chance of being placed in each group. 2 Radiation-induced Mucositis in patients with Oral cavity Squamous Cell Carcinoma. Intervention 1: Intervention group: taking mucosamin spray for 3-4 times/day. Intervention 2: Control group: taking standard treatment (magnesium- aluminium-hydroxide, diphenhydramine and nystatin) for 3 times/day. Yes - There is a plan to make this available What will be shared: The checklist will include demographic information (age, sex), complete medical and surgical history, physical examination, and clinical disease conditions for each patient. The oral mucositis oncology radiotherapy scoring table will be filled for each patient. At the end of the study this information can be shared When: Start of access period 6 months after printing results To whom: Researchers working in academia and people in the industry. Conditions: To continue investigations in this field and similar fields by other researchers and For comparison as a control group in similar studies Where to obtain: saeede_khaki@yahoo.com Saeedeh Khaki Namazi Hospital, Shiraz, Radiotherapy Department 07136125367 How to obtain: Send the research project to the following email address saeede_khaki@yahoo.com Comments:
public Saeedeh khaki
Radiation Oncology Department, Namazi hospital, Namazi square
Shiraz Iran (Islamic Republic of) 71937-11351 +98 71 3612 5367 saeede_khaki@yahoo.com Shiraz University of Medical Sciences scientific Hamid Nasrollahi
Radiation Oncology Department, Namazi hospital, Namazi square
Shiraz Iran (Islamic Republic of) 71937-11351 +98 71 3647 5877 nasrolahih@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Non-metastatic oral cavity squamous cell carcinoma with oral mucositis induced by radiation People aged 18-75 years 18 years 75 years Both Patients with systemic disease which impairs wound healing (diabetes) Muco-cutaneous disease Poor oral hygiene C00-C14 Malignant neoplasms of lip, oral cavity and pharynx Treatment - Drugs Treatment - Drugs Intervention group: taking mucosamin spray for 3-4 times/day Control group: taking standard treatment (magnesium- aluminium-hydroxide, diphenhydramine and nystatin) for 3 times/day The degree of oral cavity mucositis induced by Radiotherapy. Timepoint: Oral cavity examination weekly from the first week of radiotherapy to two weeks after the radiotherapy. Method of measurement: Oral Mucositis Oncology Radiotherapy Group Scoring Table. Severity of pain. Timepoint: Weekly patient visit from the first week of radiotherapy to two weeks after the radiotherapy. Method of measurement: Patient's history and complaint. Arena Life Science Company Approved 2019-03-09 Ethics committee of Shiraz University of Medical Sciences Faculty of medicine, Zand avenue Shiraz Fars Iran (Islamic Republic of)