Evaluation of metformin gel effect on prevention of radiation acute dermatitis

Phase 3

• Conditions: Acute radiation dermatitis.; Acute radiodermatitis; L58.0

• Registration Number: IRCT20211029052907N3
• Lead Sponsor: Zanjan University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: Pending
• Sex: Female
• Target Recruitment: 52

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.