Acute radiation dermatitis. Acute radiodermatitis
Conditions
Interventions
Intervention 1: Intervention group: intervention group will use metformin gel which is made in laboratory, for 2 times a day from the first session of radiotherapy to 4 weeks after the last session.
Sponsors
Zanjan University of Medical Sciences
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: female patients age = 18 years with a histologically confirmed diagnosis of localized invasive breast carcinoma receiving 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 fields Inflammatory or metastatic breast carcinoma Concurrent chemotherapy with RT (except trastuzumab and hormonal therapy) Generalized skin disorder Connective tissue disorders Untreated surgical wounds Known allergy or hypersensitivity history to metformin or any other ingredients of the gel
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acute radiation dermatitis. 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 |
|---|---|
| Radiotherapy-induced pain. Timepoint: Patients will be evaluated for radiotherapy-induced pain weekly (after every fifth RT session). Method of measurement: The worst experienced pain will be evaluated using a visual analog scale weekly.;Skin-related quality of life. Timepoint: 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 skin-related quality of life of the patients will be appraised using the Dermatology life quality index (DLQI) score.;Radiotherapy-induced moist desquamation. Timepoint: Patients will be evaluated for radiotherapy-induced moist desquamation weekly (after every fifth RT session). 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMonireh Maham
Zanjan University of Medical Sciences
Outcome results
None listed