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IRCT20201203049585N1 IRCT 2021-02-11 Esfahan University of Medical Sciences Effects of Aloe Vera on mucositis Evaluation and comparison of the effects of Aloe vera on prevention and treatment of radiotherapy induced mucositis- Isfahan 2021 2021-02-23 anticipated 80 Complete https://irct.ir/trial/54037 interventional Randomization: Not randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Blinding description: Patients and the clinical caregiver who provides the medication and placebo and the researcher who enters the data into the checklist will be unaware of which group each patient is in. The drug and the placebo will be sidelined with the same appearance and packaging. 2-3 Head and Neck cancers. Intervention 1: Intervention group: from the beginning of radiotherapy to the end of treatment, which lasts for an average of 6 weeks for each patient, patients are advised to gargle 5 cc of the received solution for 3 minutes 3 times a day. On the day of treatment, each patient is instructed on how to take the medicine and the empty medicine bottle is delivered and filled every two weeks according to the recommended dose. The aloe vera solution will contain pure aloe vera gel plus two-tenths of a percent methyl paraben and two-hundredths of a percent propyl paraben as a preservative. Intervention 2: Control group: they receive a placebo-containing bottle with the same appearance as the medicine in the same way. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after unidentified individuals When: 6 month after publishing To whom: Researchers working in academic and scientific institutions Conditions: Use for meta analysis Where to obtain: Seyed al-shohada hospital Roya mobini Roya.mobini@gmail.com 00989131819715 How to obtain: Correspondence with Isfahan University of Medical Sciences and Department of Radiotherapy Comments:
public Roya Mobini
Seyed al-shohada hospital, Shiri bridge, Motahari street
Esfahan Iran (Islamic Republic of) 8184917911 +98 31 3775 2366 Roya.mobini@gmail.com Esfahan University of Medical Sciences scientific Nadia Najafizade
Seyed al-shohada hospital, Shiri bridge, Motahari street
Esfahan Iran (Islamic Republic of) 8184917911 +98 31 3775 2366 Nadianajafizade@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Indication of Head and Neck radiotherapy Lack of previous history of radiation Lack of any mucusitis due to radiation or any other couses Lack of evidence of distant metastasis Karnofsky Performance Status at least 70 Not to use of NSAID or Steroids or other analgesics Absence of pregnancy At least 50 gray of radiation dose 18 years no limit Both Patient request to exit Patient die due to another reason Severe adverse effects K12.33 Oral mucositis (ulcerative) due to radiation Treatment - Drugs Placebo Intervention group: from the beginning of radiotherapy to the end of treatment, which lasts for an average of 6 weeks for each patient, patients are advised to gargle 5 cc of the received solution for 3 minutes 3 times a day. On the day of treatment, each patient is instructed on how to take the medicine and the empty medicine bottle is delivered and filled every two weeks according to the recommended dose. The aloe vera solution will contain pure aloe vera gel plus two-tenths of a percent methyl paraben and two-hundredths of a percent propyl paraben as a preservative. Control group: they receive a placebo-containing bottle with the same appearance as the medicine in the same way. RTOG grading of mucusitis. Timepoint: Record of RTOG grade before and every week of treatment and end of radiation. Method of measurement: RTOG grading questionnaire. Esfahan University of Medical Sciences Approved 2021-01-22 Ethics committee of Isfahan University of Medical Sciences Isfahan University of Medical Sciences, Hezar Jarib St., Isfahan Isfahan Isfehan Iran (Islamic Republic of)