Evaluation of montelukast gel effect on prevention of radiation acute dermatitis

Phase 3

Conditions: Acute radiation dermatitis.
Acute radiodermatitis
L58.0

Registration Number: IRCT20211029052907N2

Lead Sponsor: Zanjan University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Female

Target Recruitment: 70

Inclusion Criteria

?Adult females (age =18 years) with a histologically confirmed diagnosis of localized invasive breast carcinoma
Scheduled to receive adjuvant radiotherapy at least 50 Gy after breast surgery (breast-conserving surgery or mastectomy)

Exclusion Criteria

Prior history of radiotherapy to the treatment field
Inflammatory or metastatic breast carcinoma
Concurrent chemotherapy with RT (trastuzumab and hormonal therapy were allowed)
Generalized skin disorders
Connective tissue disorders
Untreated surgical wounds
Known allergy or hypersensitivity history to montelukast or any ingredients of the gel

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary end point is to determine whether the montelukast gel 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 montelukast gel 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) from 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.