title: A double-blind, randomised, vehicle-controlled clinical study to evaluate the efficacy of MAS065D in limiting the effects of radiation on the skin: interim analysis.
abstract: Our aim was to assess the efficacy of MAS065D, a non-steroidal water-in-oil cream, in preventing and limiting skin reactions caused by radiation therapy (RT). 40 women treated with conservative breast cancer surgery followed by radiotherapy, were randomised to receive MAS065D (22 pts) or vehicle (18 pts). Radiotherapy was delivered in 20 fractions: 2.25 Gy to the whole breast plus a concomitant boost of 0.25 Gy to the tumour bed up to a total dose of 50 Gy. Evaluations of skin toxicity, erythema, and subjective symptoms were carried out weekly and 3 weeks after treatment completion. A statistically significant difference between vehicle and MAS065D groups was recorded regarding the maximum severity of skin toxicity (p < 0.0001), burning within the radiation field (p = 0.039) and desquamation (p = 0.02), in favour of the latter. We conclude that MAS065D may be considered a safe and effective treatment in the prevention and minimization of skin reactions and associated symptoms.
authors.affiliation: Division of Radiation Oncology, European Institute of Oncology, via Ripamonti, 435, Milan, Italy. cristina.leonardi@ieo.it
authors.forename: Maria Cristina
authors.initials: MC
authors.lastname: Leonardi
authors.forename: Silvia
authors.initials: S
authors.lastname: Gariboldi
authors.forename: Giovanni Battista
authors.initials: GB
authors.lastname: Ivaldi
authors.forename: Annamaria
authors.initials: A
authors.lastname: Ferrari
authors.forename: Flavia
authors.initials: F
authors.lastname: Serafini
authors.forename: Florence
authors.initials: F
authors.lastname: Didier
authors.forename: Luigi
authors.initials: L
authors.lastname: Mariani
authors.forename: Simona
authors.initials: S
authors.lastname: Castiglioni
authors.forename: Roberto
authors.initials: R
authors.lastname: Orecchia
mesh_terms: D000279:Administration, Cutaneous; D000328:Adult; D000368:Aged; D001943:Breast Neoplasms / Q000532:radiotherapy*; D003872:Dermatitis / Q000209:etiology / Q000517:prevention & control*; D003879:Dermatologic Agents / Q000008:administration & dosage* / Q000737:chemistry; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D006034:Glycyrrhetinic Acid / Q000008:administration & dosage*; D006801:Humans; D006820:Hyaluronic Acid / Q000008:administration & dosage*; D008875:Middle Aged; D009829:Oleic Acids / Q000008:administration & dosage; D010146:Pain / Q000209:etiology / Q000517:prevention & control; D010936:Plant Extracts / Q000008:administration & dosage; D010938:Plant Oils / Q000008:administration & dosage; D011537:Pruritus / Q000209:etiology / Q000517:prevention & control; D011832:Radiation Injuries / Q000188:drug therapy / Q000517:prevention & control*; D011878:Radiotherapy / Q000009:adverse effects*; D011879:Radiotherapy Dosage; D012720:Severity of Illness Index; D012867:Skin / Q000528:radiation effects*; D018709:Statistics, Nonparametric; D053778:Thiazolidines / Q000008:administration & dosage; D016896:Treatment Outcome; D027843:Vitis
chemical_list: D003879:Dermatologic Agents; D004338:Drug Combinations; D009829:Oleic Acids; D010936:Plant Extracts; D010938:Plant Oils; D053778:Thiazolidines; C515552:enoxolone, hyaluronic acid, levomenol, telmesteine, vitis vinifera drug combination; C434349:shea oleine; C091508:telmesteine; D006820:Hyaluronic Acid; D006034:Glycyrrhetinic Acid