None listed
Conditions
Brief summary
Radiotherapy is an essential element in the treatment of patients with breast cancer. The vast majority of patients with locally advanced disease need to receive postmastectomy adjuvant radiotherapy to the chest wall and many of them develop dermatitis. Acute radiation-induced skin reaction (radiation dermatitis) develops during the radiation process or a short time after radiotherapy completion. Dermatitis or severe skin reaction of irradiated chest wall can influence the patients’ quality of life negatively; lowers their tolerance for continuing treatment; and leads to treatment delay; and results in treatment failure. Although some various managements have been suggested for radiation induced dermatitis, to date, none of them have been proved as the standard of the care. One of proposed treatments for radiation-induced dermatitis is topical corticosteroids. The anti-inflammatory effects of corticosteroids may play an important role in relieving the patients’ symptoms. The efficacy of Henna (Lawsonia inermis linn) compounds in the treatment of burning and infectious wounds has been shown in different studies. Meanwhile, their antioxidant and antimicrobial activity in wound healing has been introduced in some studies. Currently, there is no standard approach to skin care in cancer patients developing radiation dermatitis. This study aimed to compare the efficacy and safety of topical Alpha ointment to topical hydrocortisone 1% ointment on healing of radiation-induced dermatitis in breast cancer patients undergoing postmastectomy chest wall radiotherapy.
Interventions
The Postmastectomy radiation portals are composed of chest wall fields in all patients and supraclavicular, post-axillary and internal mammary fields in most of them. All patients in both arms are treated with conventional fractionation with similar technique with a daily fraction of 1.8-2 Gy, with five fractions per week and over a standard duration of total of 5-6 weeks (based on physician choice). The radiation portals were composed of chest wall fields in all patients and supraclavicular, po
The Postmastectomy radiation portals are composed of chest wall fields in all patients and supraclavicular, post-axillary and internal mammary fields in most of them. All patients in both arms are treated with conventional fractionation with similar technique with a daily fraction of 1.8-2 Gy, with five fractions per week and over a standard duration of total of 5-6 weeks (based on physician choice). The radiation portals were composed of chest wall fields in all patients and supraclavicular, post-axillary and internal mammary fields in most of them. All patients will receive a total dose of 45-50.4 Gy. patients in study arm will apply themselves 1 millimeter thickness of topical Alpha ointment twice daily (n = 30) immediately after completing postmastectomy chest wall radiotherapy with a median dose of 45-50 Gy. In addition, all patients are recommended to take daily chest wall simple washing with mild soap.
Sponsors
Shiraz University of Medical Sciences
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Eligible patients have to have newly pathologically proven diagnosed locally advanced breast cancer treated with modified radical mastectomy followed by sequential adjuvant chemotherapy and chest wall radiotherapy (45-50.4 Gy), and developed grade 2 and/or 3 radiation-induced dermatitis.
Exclusion criteria
Exclusion criteria were any history of collagen vascular diseases, diabetes mellitus, taking any drugs interacting wound healing process, like systemic steroids, previous history of chest wall radiotherapy and concurrent use of chemotherapy. All patients had to sign a consent form approved by the local research ethics committee before participating in the study.
Outcome results
None listed