Randomized, self-controlled, prospective assessment of the efficacy of mometasone furoate local application in reducing acute radiation dermatitis in patients with head and neck squamous cell carcinomas

BACKGROUND: Acute radiation dermatitis (ARD) is a common adverse effect in patients undergoing radiotherapy. Mometasone furoate cream (MMF) was reported to significantly reduce ARD, especially in breast cancer. Clinically, ARD is more critical and more difficult to prevent in patients with head and neck squamous cell carcinoma (HNSCC) than in those with breast cancer, because a higher dose of radiotherapy is required in HNSCC cases. The aim of this study was to evaluate the effect of MMF local application on radiation dermatitis in patients with HNSCC. METHODS: HNSCC patients scheduled for bilateral radical radiotherapy to the neck with identical radiation doses were enrolled. One side of the neck skin (test groups) of the patients were randomized to apply a thin layer of MMF once a day from the date of first radiotherapy until either 2 weeks after end of radiotherapy or until the test side skin developed ARD lesions, while the other side of neck (control groups) didn’t apply any medication. The severity of ARD was evaluated weekly by using the modified radiation therapy oncology group score, pain intensity, and itch stages. RESULTS: Forty-one patients (82 targets) were analyzed. There was a significant difference between the ARD scores on the test side and the control side. MMF reduced the stages of ARD when the radiotherapy dose was <6000 cGY (P = .01) but showed no improvement when the dose was ≥6000 cGY (P = .699). Compared to the control side, local application of MMF significantly reduced the itch and pain scores of the test side skin regardless of the radiotherapy dose and ARD stage (P < .001) during radiotherapy. CONCLUSIONS: This study showed that MMF inunction after high-dose radiotherapy (>50 Gy) can prevent ARD, especially when the radiation dose is <6000 cGY.