CLINICAL TRIAL Topical atorvastatin 1% for prevention of skin toxicity in patients receiving radiation therapy for breast cancer: a randomized, double-blind, placebo-controlled trial Arash Ghasemi 1 & Zahra Ghashghai 2,3 & Jafar Akbari 4 & Jamshid Yazdani-Charati 5 & Ebrahim Salehifar 6 & Seyed Jalal Hosseinimehr 2 Received: 30 April 2018 /Accepted: 28 September 2018 # Springer-Verlag GmbH Germany, part of Springer Nature 2018 Abstract Background and purpose The purpose of this randomized, placebo-controlled, double-blind study was to investigate the preven- tive effect of topical administration of atorvastatin (ATV) on the acute radiation-induced skin toxicity in patients with breast cancer. Patients and methods Seventy breast cancer patients were randomly assigned to use topical ATV 1% or placebo gels during radiotherapy twice daily. Radiation-induced dermatitis was classified according to the radiation therapy oncology group (RTOG) criteria, as well as pain and itching were scored according to VAS (visual analogue scale) for 6 weeks of treatment. Results Topical administration of ATV gel during radiotherapy reduced significantly radiation-induced breast swelling, itching, and pain in breast cancer patients by factors of 1.8, 1.7, and 1.5, respectively. ATV reduced the redness caused by radiotherapy in patients as compared with placebo; however, this difference was statistically not significant. Conclusion ATV was able to reduce significantly itching, breast edema, and pain in patients during radiotherapy. Keywords Atorvastatin . Skin toxicity . Radiotherapy . Radioprotective Introduction Breast cancer is the most common cancer and also the leading cause of cancer mortality in women worldwide. More than one million new breast cancer cases are annually diagnosed in the world [1, 2]. Management of breast cancer is multimod- al involving surgery, radiotherapy, chemotherapy, and hor- monal therapy. Radiotherapy is used in patients with early stage breast cancer after breast conservation surgery and in locally advanced breast cancer patients post-mastectomy [3]. Radiotherapy has an established role in reducing the rate of local relapse in breast cancer patients who have undergone breast-conserving breast surgery. Skin toxicity of the area be- ing treated is an uncomfortable side effect of radiation therapy [3]. The skin injury may limit the duration of treatment and may have a negative effect on quality of life of women with breast cancer [4, 5]. Several clinical trials have been per- formed for prevention of skin injury during radiotherapy using different interventions, including Aloe vera, allantoin, beclomethasone, recombinant human epidermal growth factor (rhEGF), biafine, and lipiderm [6–10]. Ionizing radiation- Electronic supplementary material The online version of this article (https://doi.org/10.1007/s00228-018-2570-x) contains supplementary material, which is available to authorized users. * Seyed Jalal Hosseinimehr sjhosseinim@yahoo.com; sjhosseinim@mazums.ac.ir 1 Department of Radiology and Radiation Oncology, Faculty of Medicine, Mazandaran University of Medical Sciences, Sari, Iran 2 Department of Radiopharmacy, Faculty of Pharmacy, Pharmaceutical Sciences Research Center, Mazandaran University of Medical Sciences, Sari, Iran 3 Student Research Committee, Mazandaran University of Medical Sciences, Sari, Iran 4 Department of Pharmaceutics, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran 5 Department of Biostatistics, Health Sciences Research Center, Addiction Institute, Mazandaran University of Medical Sciences, Sari, Iran 6 Department of Clinical Pharmacy, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran European Journal of Clinical Pharmacology https://doi.org/10.1007/s00228-018-2570-x