TY - JOUR
T1 - A double-blind, randomised, vehicle-controlled clinical study to evaluate the efficacy of MAS065D in limiting the effects of radiation on the skin
T2 - Interim analysis
AU - Leonardi, Maria Cristina
AU - Gariboldi, Silvia
AU - Ivaldi, Giovanni Battista
AU - Ferrari, Annamaria
AU - Serafini, Flavia
AU - Didier, Florence
AU - Mariani, Luigi
AU - Castiglioni, Simona
AU - Orecchia, Roberto
PY - 2008/5
Y1 - 2008/5
N2 - 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.
AB - 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.
KW - Breast
KW - MAS065D
KW - Radiation-induced dermatitis
KW - Skin care
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U2 - 10.1684/ejd.2008.0396
DO - 10.1684/ejd.2008.0396
M3 - Article
C2 - 18474463
AN - SCOPUS:44949129007
VL - 18
SP - 317
EP - 321
JO - European Journal of Dermatology
JF - European Journal of Dermatology
SN - 1167-1122
IS - 3
ER -