Mometasone Furoate Significantly Reduces Radiation Dermatitis in Patients Undergoing Breast Radiation Therapy: A Double-Blind Randomized Control Trial in 120 Patients


      The most common acute side effect of patients receiving radiation therapy to the breast/chest wall is radiation induced dermatitis. Despite this, there is no accepted intervention to prevent or treat it. A previous study by Bostrom et al showed Mometasone Furoate (M) cream was superior to Diprobase (D) in a study of 50 breast cancer patients. We sought to repeat this study in a larger cohort of 120 patients.


      Patients were recruited and stratified by whether they had treatment to the breast alone, addition of a boost, or chest wall treatment and according to their smoking habits. Patients were treated with 40 Gy in 2.67 Gy fractions over 3 weeks. Radiation dermatitis was assessed once a week for 6 weeks using a modified Radiation Therapy Oncology Group (RTOG) acute radiation score and objective measurements were taken with an erythema meter using reflectance spectrophotometry. Quality of life was assessed using the Dermatology Quality of Life (DQLI) Index and the level of psychological distress by the Hospital Anxiety and Depression (HAD) scale.


      The RTOG scores were slightly less for patients receiving the steroid cream;- mean treatment difference (D - M) was 0.123, 95% CI (0.002, 0.244), p = 0.046. The analysis of the maximum RTOG score, treating the scores as ordered categorical outcome shows a statistically significant effect of M. The odds ratio of having a lower RTOG score on M than on D is 2.38, 95% CI (1.16, 4.90), p = 0.018. The erythema readings were lower for M than D, with an average estimate of treatment difference over the six week period to be 8.98, 95% CI (2.02, 15.94), p = 0.012. The DQLI score was greater for the patients receiving M than D at the start of treatment but after week 3 was lower for M than D. The DQLI correlated with the HAD score and when corrected for there was a significant difference in favor of M.


      This study showed that Mometasone Furoate cream is of benefit in the prevention of radiation induced dermatitis, and should be the standard of care in patients receiving radiation therapy in anatomic sites that may cause skin reaction.


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