International journal of clinical oncology · 2012
A Dermatitis Control Program (DeCoP) for head and neck cancer patients receiving radiotherapy: a prospective phase II study.
Клиническое исследование II фазыСтатьяПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Zenda Sadamoto, Ishi Shinobu, Kawashima Mitsuhiko, Arahira Satoko, Tahara Makoto, Hayashi Ryuichi, Kishimoto Seiji, Ichihashi Tomiko
Аннотация
PURPOSE: We speculated that a systematic program to manage radiation dermatitis might decrease the incidence of severe or fatal cases in head and neck cancer patients receiving radiotherapy. Here, we conducted a prospective phase II study to clarify the clinical benefit of a Dermatitis Control Program (DeCoP) that did not use corticosteroids.
PATIENTS AND METHODS: Head and neck cancer patients scheduled to receive definitive or postoperative radiotherapy were enrolled. Radiation dermatitis was managed with a DeCoP consisting of a three-step ladder: Step 1, gentle washing; Step 2, gentle washing and moistening of the wound-healing environment; Step 3, prevention against infection, gentle washing and moistening of the wound-healing environment. The primary endpoint was the incidence of grade 4 dermatitis.
RESULTS: A total of 113 patients were registered between January 2009 and February 2010. Eighty patients received radiotherapy as an initial approach, while the remaining 33 received radiotherapy postoperatively. Grade 3 and 4 dermatitis events occurred in 11 (9.7%) and 0 (0%, 95% confidence interval 0-3.2%) patients, respectively. Median radiation dose at the onset of grade 2 dermatitis was 61.5 Gy (range 36-70 Gy) and median period between onset and recovery was 14 days (range 1-46 days).
CONCLUSION: The Dermatitis Control Program has promising clinical potential. Radiation dermatitis might be manageable if gentle washing and moistening of the wound-healing environment is done.
PATIENTS AND METHODS: Head and neck cancer patients scheduled to receive definitive or postoperative radiotherapy were enrolled. Radiation dermatitis was managed with a DeCoP consisting of a three-step ladder: Step 1, gentle washing; Step 2, gentle washing and moistening of the wound-healing environment; Step 3, prevention against infection, gentle washing and moistening of the wound-healing environment. The primary endpoint was the incidence of grade 4 dermatitis.
RESULTS: A total of 113 patients were registered between January 2009 and February 2010. Eighty patients received radiotherapy as an initial approach, while the remaining 33 received radiotherapy postoperatively. Grade 3 and 4 dermatitis events occurred in 11 (9.7%) and 0 (0%, 95% confidence interval 0-3.2%) patients, respectively. Median radiation dose at the onset of grade 2 dermatitis was 61.5 Gy (range 36-70 Gy) and median period between onset and recovery was 14 days (range 1-46 days).
CONCLUSION: The Dermatitis Control Program has promising clinical potential. Radiation dermatitis might be manageable if gentle washing and moistening of the wound-healing environment is done.