{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,3]],"date-time":"2026-03-03T12:18:06Z","timestamp":1772540286484,"version":"3.50.1"},"reference-count":13,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2020,5,25]],"date-time":"2020-05-25T00:00:00Z","timestamp":1590364800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2020,5,25]],"date-time":"2020-05-25T00:00:00Z","timestamp":1590364800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/100013276","name":"Interreg","doi-asserted-by":"publisher","award":["087-1.1-18"],"award-info":[{"award-number":["087-1.1-18"]}],"id":[{"id":"10.13039\/100013276","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Trials"],"published-print":{"date-parts":[[2020,12]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>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\u2019 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This randomized trial compares standard care supported by a reminder app (Arm A) to standard care alone (Arm B) with respect to grade\u2009\u2265\u20092 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\u2009\u2265\u20093 at 60 Gy and both grade\u2009\u2265\u20092 and grade\u2009\u2265\u20093 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\u2009\u2265\u20092 radiation dermatitis (primary endpoint) and oral mucositis (secondary endpoint) can be reduced by 20%.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Discussion<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"http:\/\/clinicaltrials.gov\">clinicaltrials.gov<\/jats:ext-link>\n                      (\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/clinicaltrials.gov\/show\/NCT04110977\">NCT04110977<\/jats:ext-link>\n                      ). Registered on September 27, 2019. First patient is planned to be included in December 2019.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1186\/s13063-020-04307-0","type":"journal-article","created":{"date-parts":[[2020,5,25]],"date-time":"2020-05-25T10:02:58Z","timestamp":1590400978000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":15,"title":["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"],"prefix":"10.1186","volume":"21","author":[{"given":"Dirk","family":"Rades","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Carlos Andres","family":"Narvaez","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Claudia","family":"Doemer","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stefan","family":"Janssen","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Denise","family":"Olbrich","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Soeren","family":"Tvilsted","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Antonio J.","family":"Conde-Moreno","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jon","family":"Cacicedo","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2020,5,25]]},"reference":[{"key":"4307_CR1","doi-asserted-by":"publisher","first-page":"1037","DOI":"10.1016\/j.ijrobp.2010.03.033","volume":"80","author":"D Rades","year":"2011","unstructured":"Rades D, Kronemann S, Meyners T, Bohlen G, Tribius S, Kazic N, et al. Comparison of four cisplatin-based radiochemotherapy regimens for nonmetastatic stage III\/IV squamous cell carcinoma of the head and neck. Int J Radiat Oncol Biol Phys. 2011;80:1037\u201344.","journal-title":"Int J Radiat Oncol Biol Phys"},{"key":"4307_CR2","doi-asserted-by":"publisher","first-page":"1108","DOI":"10.1016\/j.ijrobp.2007.07.2380","volume":"70","author":"D Rades","year":"2008","unstructured":"Rades D, Stoehr M, Kazic N, Hakim SG, Walz A, Schild SE, et al. Locally advanced stage IV squamous cell carcinoma of the head and neck: impact of pre-radiotherapy hemoglobin level and interruptions during radiotherapy. Int J Radiat Oncol Biol Phys. 2008;70:1108\u201314.","journal-title":"Int J Radiat Oncol Biol Phys"},{"key":"4307_CR3","doi-asserted-by":"publisher","first-page":"675","DOI":"10.1016\/j.ijrobp.2009.08.004","volume":"78","author":"MD Fesinmeyer","year":"2010","unstructured":"Fesinmeyer MD, Mehta V, Blough D, Tock L, Ramsey SD. Effect of radiotherapy interruptions on survival in Medicare enrollees with local and regional head-and-neck cancer. Int J Radiat Oncol Biol Phys. 2010;78:675\u201381.","journal-title":"Int J Radiat Oncol Biol Phys"},{"key":"4307_CR4","doi-asserted-by":"publisher","first-page":"535","DOI":"10.1016\/j.oraloncology.2006.05.006","volume":"43","author":"D Rades","year":"2007","unstructured":"Rades D, Fehlauer F, Wroblesky J, Albers D, Schild SE, Schmidt R. Prognostic factors in head-and-neck cancer patients treated with surgery followed by intensity-modulated radiotherapy (IMRT), 3D-conformal radiotherapy, or conventional radiotherapy. Oral Oncol. 2007;43:535\u201343.","journal-title":"Oral Oncol"},{"key":"4307_CR5","doi-asserted-by":"publisher","first-page":"198","DOI":"10.1007\/s00066-008-1825-3","volume":"184","author":"D Rades","year":"2008","unstructured":"Rades D, Stoehr M, Meyners T, Bohlen G, Nadrowitz R, Dunst J, et al. 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The study is conducted in accordance with the principles laid out in the Declaration of Helsinki and in accordance with the principles of GCP (ICH-GCP E6). Patients are included after giving written informed consent.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate {24}"}},{"value":"Not applicable.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication {32}"}},{"value":"Dirk Rades and Stefan Janssen are members of the editorial board of <i>BMC Cancer<\/i>. Otherwise, the authors declare that they have no competing interest related to the study presented here.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests {28}"}}],"article-number":"424"}}