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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.

BackgroundThe aim of the present trial is to investigate a new option of skin protection in order to reduce the rate of grade ≥ 2 skin toxicity in patients receiving radiotherapy alone or radiochemotherapy for locally advanced squamous cell carcinoma of the head-and-neck (SCCHN).Methods / DesignThis is a randomized, active-controlled, parallel-group multi-center trial that compares the following treatments of radiation dermatitis in patients with head-and-neck cancer: Mepitel® Film (Arm A) vs. standard care (Arm B). The primary aim of this trial is to investigate the rate of patients experiencing grade ≥ 2 radiation dermatitis (according to Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.03) until 50 Gy of radiotherapy. Evaluation until 50 Gy of radiotherapy has been selected as the primary endpoint, since up to 50 Gy, the irradiated volume includes the primary tumor and the bilateral cervical and supraclavicular lymph nodes, and, therefore, is similar in all patients. After 50 Gy, irradiated volumes are very individual, depending on location and size of the primary tumor, involvement of lymph nodes, and the treatment approach (definitive vs. adjuvant). In addition, the following endpoints will be evaluated: Time to grade 2 radiation dermatitis until 50 Gy of radiotherapy, rate of patients experiencing grade ≥ 2 radiation dermatitis during radio(chemo)therapy, rate of patients experiencing grade ≥ 3 skin toxicity during radio(chemo)therapy, adverse events, quality of life, and dermatitis-related pain. Administration of Mepitel® Film will be considered to be clinically relevant, if the rate of grade ≥ 2 radiation dermatitis can be reduced from 85% to 65%.DiscussionIf administration of Mepitel® Film instead of standard care will be able to significantly reduce the rate of grade ≥ 2 radiation dermatitis, it could become the new standard of skin care in patients irradiated for SCCHN.Trial registrationclinicaltrials.gov NCT03047174. Registered on 26th of January, 2017. First patient included on 9th of May, 2017.

Background/Aim: The anticipation of radiotherapy can cause distress and sleep disorders, which may be aggravated by the COVID-19 pandemic. This study investigated sleep disorders in a large cohort of patients with breast cancer before and during the pandemic. Patients and Methods: Twenty-three characteristics were retrospectively analyzed for associations with pre-radiotherapy sleep disorders in 338 patients. Moreover, 163 patients presenting before and 175 patients presenting during the COVID-19 pandemic were compared for sleep disorders. Results: Sleep disorders were significantly associated with age ≤60 years (p=0.006); high distress score (p<0.0001); more emotional (p<0.0001), physical (p<0.0001) or practical (p<0.0001) problems; psycho-oncological need (p<0.0001); invasive cancer (p=0.003); chemotherapy (p<0.001); and hormonal therapy (p=0.006). Sleep disorders were similarly common in both groups (prior to vs. during the pandemic: 40% vs. 45%, p=0.38). Conclusion: Although additional significant risk factors for sleep disorders were identified, the COVID-19 pandemic appeared to have no significant impact on sleep disorders in patients scheduled for irradiation of breast cancer.Breast cancer is one of the most common cancer types worldwide (1). In the vast majority of patients with primary breast cancer, the treatment regimen includes adjuvant radiotherapy (2). Being scheduled for radiotherapy can cause significant distress for patients, which may be associated with sleep disorders. According to previous studies, sleep disorders are quite common in patients with breast cancer (3,4).Controversy exists regarding the point in time during a patient's course when sleep orders are most prevalent. In a study that investigated sleeping habits in 33 patients with breast cancer and 23 with prostate cancer during a course of radiotherapy plus 6-month follow-up, sleep disorders occurred mainly before and at the beginning of the treatment (5). In a population-based epidemiological study including 465 patients with breast cancer and 263 with prostate cancer, sleep disorders increased during the period of treatment due to radiationrelated side-effects (6). To date, only a few studies have investigated the prevalence of pre-radiotherapy sleep disorders and corresponding risk factors (4, 7, 8). Therefore, a major goal of the current study was the identification of additional risk factors for pre-radiotherapy sleep disorders in a large cohort of patients with primary breast cancer.Distress and pre-radiotherapy sleep disorders may be aggravated by the Coronavirus Disease 2019 (COVID-19) pandemic. The majority of patients with cancer belong to the high-risk group because of immuno-suppression due to malignant disease or anticancer treatment (9-12). The studies reported so far have provided conflicting results regarding the impact of the COVID-19 pandemic on distress and sleep disorders in patients with cancer (13)(14)(15)(16)(17). No study has particularly focused on the impact of the COVID-19 pandemic on the prevalence of slee...

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