Radiation Dermatitis. Acute radiodermatitis
Conditions
Interventions
Intervention 1: Intervention group: Breast cancer patients (stage I-?) undergoing radiotherapy who take 20 milligram tablet of melatonin every night from first fraction to two weeks after last radioth
Sponsors
Shahid Beheshti University
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Women aged above 18 years old with breast cancer diagnosis (stage I-?) Previous surgery (lumpectomy or mastectomy) Completion of chemotherapy 4 weeks prior to study entry (if it was prescribed for the patient) Radiotherapy regimen with fractionation daily dose of 2 Gy
Exclusion criteria
Exclusion criteria: Pregnancy Breast-feeding Serious functional disorders of the liver Epilepsy Diabetes mellitus type 1 or 2 Uncontrolled hypertension Concurrent connective tissue disorders History of chest radiation radiotherapy History of asthma or severe allergic reactions Blood coagulation disorders Concurrent immunosuppressive treatments Taking sedative or anticoagulant drugs at the same time Sensitivity to melatonin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Radiation dermatitis grade ?. Timepoint: Determination of the grade of radiation dermatitis through direct inspection by physician from the beginning of the study to two weeks after the last radiotherapy fraction weekly. Method of measurement: Based on the standard grading criteria of CTCAE (Common Toxicity Criteria for Adverse Events, version 4.03) for cancer clinical trials. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactShadi Shafaghi
Shahid Beheshti University of Medical Sciences
Outcome results
None listed