Miller, R.C., Schwartz, D.J., Sloan, J.A., Griffin, P.C., Deming, R.L., Anders, J.C., . . . Martenson, J.A. (2011). Mometasone furoate effect on acute skin toxicity in breast cancer patients receiving radiotherapy: A phase III double-blind, randomized trial from the North Central Cancer Treatment Group N06C4. International Journal of Radiation Oncology, Biology, Physics, 79(5), 1460–1466.

To evaluate the effect of 0.1% mometasone furoate on a acute skin-related toxicity in patients undergoing breast or chest-wall radiotherapy

Patients were randomly assigned to either 0.1% mometasone furoate cream or an identical-looking placebo cream. Patients were to apply toe cream once daily to the area under treatment not less than four hours before or after radiation therapy. Creams were used throughout the radiation therapy course. No other topical agents were to be used. If the primary physician initiated a medication other than the study agent, the study medication was discontinued and evaluations continued according to the study protocol. Patients were evaluated at baseline and weekly by treatment providers.

• The study sample (N = 166) was comprised of patients with breast cancer.
• Other sample characteristics were not clearly reported.
   

The study took place at the May Clinic in Rochester, NY.

The study used a double-blind placebo-controlled randomized clinical trial design.

• The National Cancer Institute's Common Termonology Criteria for Adverse Events (version 3.0) was used.
• Patient-reported outcomes were measured using the Skindex-16, the Skin Toxicity Assessment Tool, a Symptom Experience Diary (rated multiple skin toxicity signs and symptoms on a 0–10 scale), and a quality-of-life self-assessment.
   

There was no significant difference between groups in the mean grade of provider-assessed radiation dermatitis. The Skindex-16 showed no statistically significant difference between groups. In the Symptom Experience Diary, patients in the mometasome arm reported less burning, itching, and redness (p < 0.02). There was no difference between groups in quality of life.

Topical mometasone furoate was associated with less burning, itching, and redness but did not show any significant effect on overall radiation-induced skin toxicity.

• No demographic data were reported. 
• It is not stated if any patients were also receiving chemotherapy or whether any patients received other topical agents as allowed. 
• The only explanation provided for the 10% dropout rate was discontinuation.

Findings suggest that topical corticosteroid use or mometasone does not significantly reduce the severity of radiodermatitis but may reduce patient symptoms of burning, itching, and redness. Though topical steroids may not prevent dermatitis, their use may help patients be more comfortable during radiation treatment.