Comparison of Efficacy and Safety Between Medical Radiation Protectants (FORRAD®) and Trolamine (Biafine) for the Management of Radiation Dermatitis in Patients With Nasopharyngeal Carcinoma Receiving IMRT

Summary

Radiation therapy remains the principal treatment for nasopharyngeal carcinoma (NPC). Although intensity modulated radiation therapy (IMRT) has been widely used in China nowadays, radiation dermatitis is still common. It has an impact on pain and quality of life, and if severe, may lead to interruption of the radiation schedule for the patient. Trolamine (Biafine; Genmedix Ltd, France) is commonly prescribed at the beginning of radiotherapy for preventing acute radiation-induced skin toxicity in China. However, as long as grade ≥2 radiation dermatitis is developed, trolamine is not allowed to use any more. Medical Radiation Protectants (FORRAD®) is a new kind of topical agents for prevention and treatment of radiation dermatitis. It could be used during the course of radiotherapy, even when grade ≥2 dermatitis is developed. This randomized phase II study is aimed to assess the effectiveness and safety of Medical Radiation Protectants (FORRAD®) for the prevention and treatment of acute radiation-induced dermatitis of grade 3 or higher during IMRT for patients with NPC, compared with trolamine.

Timeline

Start

2016-04

Primary completion

2017-06

Completion

2017-06

Publications

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• Background Rollmann DC, Novotny PJ, Petersen IA, Garces YI, Bauer HJ, Yan ES, Wahner-Roedler D, Vincent A, Sloan JA, Issa Laack NN. Double-Blind, Placebo-Controlled Pilot Study of Processed Ultra Emu Oil Versus Placebo in the Prevention of Radiation Dermatitis. Int J Radiat Oncol Biol Phys. 2015 Jul 1;92(3):650-8. doi: 10.1016/j.ijrobp.2015.02.028. Epub 2015 Apr 28.
• Background Fisher J, Scott C, Stevens R, Marconi B, Champion L, Freedman GM, Asrari F, Pilepich MV, Gagnon JD, Wong G. Randomized phase III study comparing Best Supportive Care to Biafine as a prophylactic agent for radiation-induced skin toxicity for women undergoing breast irradiation: Radiation Therapy Oncology Group (RTOG) 97-13. Int J Radiat Oncol Biol Phys. 2000 Dec 1;48(5):1307-10. doi: 10.1016/s0360-3016(00)00782-3.
• Background Pommier P, Gomez F, Sunyach MP, D'Hombres A, Carrie C, Montbarbon X. Phase III randomized trial of Calendula officinalis compared with trolamine for the prevention of acute dermatitis during irradiation for breast cancer. J Clin Oncol. 2004 Apr 15;22(8):1447-53. doi: 10.1200/JCO.2004.07.063.

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