Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology · 2013
A potent steroid cream is superior to emollients in reducing acute radiation dermatitis in breast cancer patients treated with adjuvant radiotherapy. A randomised study of betamethasone versus two moisturizing creams.
Клиническое исследование III фазыСравнительное исследованиеСтатьяРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Ulff Eva, Maroti Marianne, Serup Jörgen, Falkmer Ursula
Аннотация
BACKGROUND AND PURPOSE: The aim was to investigate whether treatment with potent local steroids can reduce signs and symptoms of acute radiation dermatitis in breast cancer patients undergoing adjuvant radiotherapy (RT) compared to emollient creams.
MATERIAL AND METHODS: The study was randomised and double-blinded. Patients with breast cancer who had undergone mastectomy or breast-conserving surgery were included when they started adjuvant 3-D planned RT. In all, 104 patients were randomised 2:1:1 to three treatment groups, i.e. betamethasone+Essex® cream, Essex® cream or Canoderm® cream. The patients themselves treated the irradiated area during the radiation period (5 weeks) and two weeks after cessation of RT. Signs of RT dermatitis were measured qualitatively with RTOG clinical scoring and quantitatively by colorimeter. In addition, the patients' symptoms were recorded as well as the Fitzpatrick skin type. There was a statistically significant difference (p=0.05) in skin reactions when assessed with RTOG in favour of the group treated with the potent steroid. Patient-related symptoms did not differ between the treatment groups. The effect of the steroid was prominent in three subgroups, i.e. (i) patients treated with ablation of the breast, (ii) patients receiving RT to the armpit and the supraclavicular fossa, and (iii) patients with Fitzpatrick skin type 1.
CONCLUSIONS: Treatment with betamethasone cream is more efficient than moisturizers for the control of acute RT dermatitis in patients treated with adjuvant RT for breast cancer.
MATERIAL AND METHODS: The study was randomised and double-blinded. Patients with breast cancer who had undergone mastectomy or breast-conserving surgery were included when they started adjuvant 3-D planned RT. In all, 104 patients were randomised 2:1:1 to three treatment groups, i.e. betamethasone+Essex® cream, Essex® cream or Canoderm® cream. The patients themselves treated the irradiated area during the radiation period (5 weeks) and two weeks after cessation of RT. Signs of RT dermatitis were measured qualitatively with RTOG clinical scoring and quantitatively by colorimeter. In addition, the patients' symptoms were recorded as well as the Fitzpatrick skin type. There was a statistically significant difference (p=0.05) in skin reactions when assessed with RTOG in favour of the group treated with the potent steroid. Patient-related symptoms did not differ between the treatment groups. The effect of the steroid was prominent in three subgroups, i.e. (i) patients treated with ablation of the breast, (ii) patients receiving RT to the armpit and the supraclavicular fossa, and (iii) patients with Fitzpatrick skin type 1.
CONCLUSIONS: Treatment with betamethasone cream is more efficient than moisturizers for the control of acute RT dermatitis in patients treated with adjuvant RT for breast cancer.
Предметные рубрики MeSH
Acute DiseaseAdministration, TopicalAgedAnalysis of VarianceBetamethasoneBreast NeoplasmsDose-Response Relationship, DrugDouble-Blind MethodDrug Administration ScheduleEmollientsFemaleFollow-Up StudiesHumansMastectomy, SegmentalMethylprednisoloneMiddle AgedRadiodermatitisRadiotherapy DosageRadiotherapy, AdjuvantRadiotherapy, ConformalReference ValuesSeverity of Illness IndexTreatment Outcome