A Randomized Clinical Study of Mometasone Furoate Cream in Prevention of Radiation Dermatitis in Head and Neck Squamous Cell Carcinoma Patients Receiving Radiation Therapy (NCT02495064)

A series of reports show mometasone furoate cream can relieve acute radiation dermatitis in patients with breast cancer from 2001 to 2014. Patients with head and neck cancer need to receive higher radiation doses, so the acute radiation dermatitis incidence and level are often higher than in breast cancer patients receiving radiation therapy. But there is still no specific drug can obviously alleviate the radiation dermatitis. This randomized controlled clinical trial is studying mometasone furoate cream in preventing and reducing acute radiation dermatitis in patients receiving radiation therapy for head and neck squamous cell carcinoma. This study was registered on the “clinical Trials” in 2015, and its authorized experimental code is: NCT02495064. Bilateral neck skins of patient were treated with the same dose of radiotherapy. One of side neck skin was randomly into the treatment group, and another side was the control group. Neck skin of treatment group was used mometasone furoate cream every day after radiotherapy, and the control group was used noting. According to radiation dermatitis grading standard of RTOG, acute radiation dermatitis was independent assessed by two radiation oncologists every Friday after radiotherapy. total of 80 patients were enrolled in this study. At present, 62 eligible patients have been treated. Of the 124 subjects, 36 subjects occurred I grade acute radiation dermatitis, 60 subjects occurred II grade radiation dermatitis, 24 subjects occurred III grade radiation dermatitis, and 4 radiation dermatitis occurred IV grade radiation dermatitis. If the radiotherapy dose of neck skin were lower than 60Gy, radiation dermatitis were often I grade in treatment group and II grade in control group (P < 0.05). However, if the radiotherapy dose of neck skin were greater than or equal to 60Gy, radiation dermatitis were often III-IV grade, and using mometasone furoate cream cannot reduce the classification of radiation dermatitis (P > 0.05). Compared control group, mometasone furoate cream can significantly reduce the itching, pain and other symptoms of skin in different radiotherapy dose (P < 0.05). Mometasone furoate cream can reduce classification of radiation dermatitis in head and neck squamous cell carcinoma patients who receive radiotherapy dose less than 60Gy, but not greater than or equal to 60Gy. And mometasone furoate cream can significantly reduce the itching, pain and other symptoms of skin.