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IRCT20211029052907N1 IRCT 2022-01-28 Zanjan University of Medical Sciences Evaluation of Esomeprazole cream effect on prevention of acute radiation dermatitis Effectiveness and safety of Esomeprazole cream in the prevention of acute radiation dermatitis in head and neck cancer patients 2022-03-21 anticipated 36 Complete https://irct.ir/trial/61342 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Patients will be randomly assigned to 2 groups, with the help of a computer-generated random assignment by an independent statistician who was not part of the study team. Allocation will be concealed using sequentially numbered opaque sealed envelopes, Blinding description: The patients, researchers, and radiooncologist will not be aware of the medication patients are receiving. 3 acute radiation dermatitis. Intervention 1: Intervention group: Esomeprazole cream. Intervention 2: Control group: Placebo. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information.
public Monireh Maham
Pharmacy Faculty, Zanjan University of Medical Sciences, Dr. Sobouti Blvd., Zanjan
Zanjan Iran (Islamic Republic of) 4513956184 +98 24 3347 3635 m.maham@zums.ac.ir Zanjan University of Medical Sciences scientific Monireh Maham
Pharmacy Faculty, Zanjan University of Medical Sciences, Dr. Sobouti Blvd., Zanjan
Zanjan Iran (Islamic Republic of) 4513956184 +98 24 3347 3635 m.maham@zums.ac.ir Zanjan University of Medical Sciences Iran (Islamic Republic of) Patient with histopathologically proven diagnosis of head and neck cancer Planned to receive radiotherapy with or without chemotherapy at least 60 Grays 18 years no limit Both History of previous head and neck radiotherapy Generalized skin diseases Connective tissue diseases Untreated surgical wounds Currently taking proton pump inhibitors History of allergy to Esomeprazole or other topical formulation excipients L58.0 Acute radiodermatitis Prevention Prevention Intervention group: Esomeprazole cream Control group: Placebo The primary endpoint is to determine whether the Esomeprazole cream can reduce the incidence of acute radiation dermatitis in comparison to placebo. Timepoint: Patients will be evaluated for acute radiation dermatitis severity weekly after every fifth RT session. Method of measurement: The severity of acute radiation dermatitis will be scored using the Radiation Therapy Oncology Group and the European Organization for Research and Treatment of Cancer (RTOG/EORTC) criteria based on the clinical presentation. The secondary outcomes are to assess if Esomeprazole cream reduces radiotherapy-induced symptoms such as pain and moist desquamation and improves the skin-related quality of life as compared to placebo. Timepoint: Patients will be evaluated for radiotherapy-induced symptoms such as pain and moist desquamation weekly after every fifth RT session. The patients will be requested to fill out the Dermatology Life Quality Index (DLQI) form considering their feelings during the past week. Method of measurement: The size and severity of moist desquamation will be assessed by the Common Terminology Criteria for Adverse Events (CTCAE, version 5.0) criteria based on the clinical presentation. The worst experienced pain will be evaluated using a visual analog scale. The skin-related quality of life of the patients was appraised using the Dermatology Life Quality Index(DLQI) score. Zanjan University of Medical Sciences Approved 2021-12-01 Research Ethics committees of Zanjan University of Medical Sciences Zanjan University of Medical Sciences, Azadi Square Zanjan Zanjan Iran (Islamic Republic of)