Acute radiation dermatitis. Acute radiodermatitis
Conditions
Interventions
Intervention 1: Intervention group: montelukast gel. Intervention 2: Control group: placebo gel.
Sponsors
Zanjan University of Medical Sciences
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMonireh Maham
Zanjan University of Medical Sciences
Outcome results
None listed