Radiotherapy-related skin toxicity (RAREST-02): A randomized trial testing the effect of a mobile application reminding head-and-neck cancer patients to perform skin care (reminder app) on radiation dermatitis

Trials

Denise Olbrich¹  Jon Cacicedo²  Antonio J. Conde-Moreno³  Dirk Rades⁴  Claudia Doemer⁴  Carlos Andres Narvaez⁴  Stefan Janssen⁵  Soeren Tvilsted⁶ 

[1] Centre for Clinical Trials Lübeck;Department of Radiation Oncology, Cruces University Hospital/ Biocruces Health Research Institute;Department of Radiation Oncology, Hospital Universitario y Politecnico La Fe;Department of Radiation Oncology, University of Lübeck;Medical Practice for Radiotherapy and Radiation Oncology;Research Projects and Clinical Optimization, Zealand University Hospital;

关键词: head-and-neck cancer;    radiotherapy;    radiation dermatitis;    oral mucositis;    reminder app;   

DOI  :  10.1186/s13063-020-04307-0

来源: DOAJ

【 摘 要 】

Abstract Background Radiotherapy of head-and-neck cancer can be associated with significant toxicities including dermatitis and oral mucositis. Severe toxicities may require interruptions of the radiation treatment associated with impairment of the patients’ prognoses. This study will investigate whether the addition of a reminder app to standard care can reduce dermatitis and oral mucositis rates during radiotherapy in these patients. Methods This randomized trial compares standard care supported by a reminder app (Arm A) to standard care alone (Arm B) with respect to grade ≥ 2 radiation dermatitis and oral mucositis at 60 Gy of radiotherapy, the minimum planned dose for patients receiving definitive or adjuvant radiotherapy for locally advanced head- and-neck cancer. Moreover, radiation-induced dermatitis and oral mucositis grade ≥ 3 at 60 Gy and both grade ≥ 2 and grade ≥ 3 at the end of radiation treatment (EOT) will be evaluated, as well as quality of life and pain. According to sample size calculations, 80 patients are required per arm within the full analysis set. Taking into account that 5% of patients will not qualify for full analysis set, 168 patients should be randomized. The impact of the reminder app will be considered clinically relevant, if the rates of grade ≥ 2 radiation dermatitis (primary endpoint) and oral mucositis (secondary endpoint) can be reduced by 20%. Discussion If the addition of a reminder app to standard care will lead to a significant reduction of radiation dermatitis and oral mucositis, it could become a helpful tool for patients with head-and-neck cancer during radiotherapy. Trial registration clinicaltrials.gov ( NCT04110977 ). Registered on September 27, 2019. First patient is planned to be included in December 2019.

【 授权许可】

Unknown