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IRCT20180924041119N1 IRCT 2018-10-12 Islamic Azad University Effect of vitamin E on Prevention of oral inflammation Effect of vitamin E on prevention of oral mucositis in patients undergoing head and neck radiotherapy 2018-08-23 anticipated 24 Complete https://irct.ir/trial/34114 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: The samples are stratified randomized, so that patients who are included in the study are stratified in terms of age above 50 years of age and of possible chemotherapy at the same time as radiotherapy. Randomization was performed by a 4‑block stratified technique, Blinding description: Although patients are aware of the study and are given written consent, they are unaware of the fact that the medication is effective or placebo. Also, the controlling person, who examines patients for follow up from the beginning to the end of the study at the hospital, is unaware of which patient is in what group. 3 Prevention of oral mucositis caused by head and neck radiotherapy. Intervention 1: Intervention group: Vitamin E, a daily dose of 200 mg, manufactured by the Dana Pharmaceutical Company,it is prescribed from first session of radiotherapy to 8 weeks. Intervention 2: Control group: Placebo, in the same color and size as the original drug, was produced by the Dana Company and it has used in the same manner. No - There is not a plan to make this available Justification or reason for not sharing IPD is No more information
public Arash Azizi
No.9, Neyestan 9, Pasdaran st
Tehran Iran (Islamic Republic of) 1958517511 +98 21 2258 0925 drarashazizi@yahoo.com Islamic Azad University scientific Arash Azizi
No.9, Neyestan 9, Pasdaran st
Tehran Iran (Islamic Republic of) 1958517511 +98 22580925 drarashazizi@yahoo.com Islamic Azad University Iran (Islamic Republic of) Patients who have a radiotherapy indication of at least 50Gy throughout the study At least two areas in the radiotherapy field from mouth are involved the tumor 18 years no limit Both Patients with diabetes Patients with Candidiasis Patients who use tobacco. Prevention Prevention Intervention group: Vitamin E, a daily dose of 200 mg, manufactured by the Dana Pharmaceutical Company,it is prescribed from first session of radiotherapy to 8 weeks. Control group: Placebo, in the same color and size as the original drug, was produced by the Dana Company and it has used in the same manner. Percentage of Vitamin E Preventional Effects on Oral Mucositis. Timepoint: At the beginning of the study (before the intervention) and 7, 14, 21, 28, 35, 42, 49 and 56 days after the start of taking the drug and placebo. Method of measurement: Visual Analogue Scale. Azad University of Tehran Medical Sciences Approved 2018-06-02 Ethics committee of Azad Universty of Tehran Medical Sciences No. 4, Neyestan 10, Pasdaran st, Tehran Tehran Tehran Iran (Islamic Republic of)