Evaluation of Esomeprazole cream effect on prevention of acute radiation dermatitis

Phase 3

Conditions: acute radiation dermatitis.
Acute radiodermatitis
L58.0

Registration Number: IRCT20211029052907N1

Lead Sponsor: Zanjan University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 36

Inclusion Criteria

Patient with histopathologically proven diagnosis of head and neck cancer
Planned to receive radiotherapy with or without chemotherapy at least 60 Grays

Exclusion Criteria

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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.