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.

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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Background/Aim: Radiotherapy and radiochemotherapy are common treatments for rectal and anal cancer. Anticipation of treatment may cause distress and sleep disorders. This study aimed to identify risk factors for sleep disorders. Patients and Methods: In 42 patients with rectal or anal cancer scheduled for radiotherapy, 16 characteristics were analyzed for associations with pre-radiotherapy sleep disorders including age, gender, performance score, comorbidity, patient's or family history of additional cancer/melanoma, distress score, emotional/physical/practical problems, tumor site and stage, surgery and relation to COVID-19 pandemic. Results: Overall prevalence of pre-radiotherapy sleep disorders was 42.9%. Sleep disorders were significantly associated with Karnofsky performance score 60-80 (p=0.044), Charlson comorbidity index ≥3 (p=0.0012), distress score 6-10 (p=0.00012), and more emotional (p=0.0012), physical (p=0.0004) or practical (p=0.033) problems. A trend was found for female gender (p=0.061). Conclusion: Sleep disorders were common in patients with rectal or anal cancer scheduled for radiotherapy. Risk factors can help identify patients requiring psychooncological support already prior to the start of radiotherapy.

Background Gliomas are often associated with symptoms including seizures. Most patients with high-grade gliomas are treated with radiotherapy or radio-chemotherapy. Since irradiation causes inflammation, it may initially aggravate symptoms. Studies focusing on seizure activity during radiotherapy for gliomas are not available. Such knowledge may improve patient monitoring and anti-epileptic treatment. This study evaluates seizure activity during radiotherapy for high-grade gliomas. Methods The primary objective this prospective interventional study is the evaluation of seizure activity during a course of radiotherapy for high-grade gliomas. Progression of seizure activity is defined as increased frequency of seizures by > 50%, increased severity of seizures, or initiation/increase by ≥25% of anti-epileptic medication. Seizure frequency up to 6 weeks following radiotherapy and electroencephalography activity typical for epilepsy will also be evaluated. Patients keep a seizure diary during and up to 6 weeks following radiotherapy. Every day, they will document number (and type) of seizures and anti-epileptic medication. Once a week, the findings of the diary are checked and discussed with a neurologist to initiate or adjust anti-epileptic medication, if necessary. Patients complete a questionnaire regarding their satisfaction with the seizure diary. If the dissatisfaction rate is > 40%, the seizure diary will be considered not suitable for the investigated indication. Thirty-five patients (32 patients plus drop-outs) should be enrolled. With this sample size, a one-sample binomial test with a one-sided significance level of 2.5% has a power of 80% to yield statistical significance, if the rate of patients with progression of seizure activity is 30% (rate under the alternative hypothesis), assuming a ‘natural’ background progression-rate of 10% without radiotherapy (null hypothesis). Discussion If an increase in seizure activity during a course of radiotherapy for high-grade glioma occurs, the findings of this study may pave the way for a larger prospective trial and will likely lead to closer patient monitoring and better anti-epileptic treatment. Trial registration clinicaltrials.gov (NCT04552756); registered on 16th of September, 2020.