• Robert C Miller, David J Schwartz, Jeff A Sloan, Patricia C Griffin, Richard L Deming, Jon C Anders, Thomas J Stoffel, Robert E Haselow, Paul L Schaefer, James D Bearden, Pamela J Atherton, Charles L Loprinzi, and James A Martenson.
• Department of Radiation Oncology, Mayo Clinic, Rochester, MN 55905, USA. miller.robert@mayo.edu
• Int. J. Radiat. Oncol. Biol. Phys. 2011 Apr 1; 79 (5): 1460-6.

PurposeA two-arm, double-blind, randomized trial was performed to evaluate the effect of 0.1% mometasone furoate (MMF) on acute skin-related toxicity in patients undergoing breast or chest wall radiotherapy.Methods And MaterialsPatients with ductal carcinoma in situ or invasive breast carcinoma who were undergoing external beam radiotherapy to the breast or chest wall were randomly assigned to apply 0.1% MMF or placebo cream daily. The primary study endpoint was the provider-assessed maximal grade of Common Terminology Criteria for Adverse Events, version 3.0, radiation dermatitis. The secondary endpoints included provider-assessed Common Terminology Criteria for Adverse Events Grade 3 or greater radiation dermatitis and adverse event monitoring. The patient-reported outcome measures included the Skindex-16, the Skin Toxicity Assessment Tool, a Symptom Experience Diary, and a quality-of-life self-assessment. An assessment was performed at baseline, weekly during radiotherapy, and for 2 weeks after radiotherapy.ResultsA total of 176 patients were enrolled between September 21, 2007, and December 7, 2007. The provider-assessed primary endpoint showed no difference in the mean maximum grade of radiation dermatitis by treatment arm (1.2 for MMF vs. 1.3 for placebo; p = .18). Common Terminology Criteria for Adverse Events toxicity was greater in the placebo group (p = .04), primarily from pruritus. For the patient-reported outcome measures, the maximum Skindex-16 score for the MMF group showed less itching (p = .008), less irritation (p = .01), less symptom persistence or recurrence (p = .02), and less annoyance with skin problems (p = .04). The group's maximal Skin Toxicity Assessment Tool score showed less burning sensation (p = .02) and less itching (p = .002).ConclusionPatients receiving daily MMF during radiotherapy might experience reduced acute skin toxicity compared with patients receiving placebo.Copyright © 2011 Elsevier Inc. All rights reserved.

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