Topical Timolol Effectiveness for prophylaxy of radiation induced dermatitis in breast cancer patients
Phase 3
- Conditions
- Radiodermatitis.Malignant neoplasm of breast
- Registration Number
- IRCT20190810044500N11
- Lead Sponsor
- Yazd University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 64
Inclusion Criteria
Patients older than 18 years with positive histology confirm invasive and localized breast cancer, who are candidates for adjuvant radiotherapy after surgery (breast conserving or mastectomy).
Adequate literacy to fill out a consent form, understand the study, use the drug, report pain and possible side effects
Exclusion Criteria
Inflammatory or metastatic carcinoma
Extensive skin diseases
Connective tissue diseases
known sensitivity to beta-antagonist drugs
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Acute Radiation Dermatitis. Timepoint: Weekly during radiotherapy and two weeks after the end of radiotherapy. Method of measurement: Based on the Radiation Therapy Oncology Group and the European Organization for Research and Treatment of Cancer (RTOG / EORTC).;Moist desquamation. Timepoint: Weekly during radiotherapy and two weeks after the end of radiotherapy. Method of measurement: Based on the Common Terminology Criteria for Adverse Events (CTCAE, version 5.0).;The worst pain experienced. Timepoint: once every two weeks. Method of measurement: Based on Dermatology Life Quality Index (DLQI).;Patient' skin phototype. Timepoint: Before starting radiotherapy. Method of measurement: Based on the Fitzpatrick skin phototype scale.
- Secondary Outcome Measures
Name Time Method Quality of Life. Timepoint: Before and after intervention. Method of measurement: According to the questionnaire EORTC QLQ-C30 (version 3).;When the complication occurs. Timepoint: From the beginning of the intervention to two weeks after the end of radiotherapy. Method of measurement: Based on the doctor's observation and the person's statements.