Improvement of Sleep Disorders During a Course of Radiotherapy for Breast Cancer - Final Results of the Prospective Interventional RADIO-SLEEP Trial.

BACKGROUND/AIM: Upcoming radiotherapy may cause distress and sleep disorders (SDO). This prospective interventional trial investigated SDO during a course of radiotherapy for breast cancer. PATIENTS AND METHODS: Fifty patients were eligible. The primary endpoint was improvement of SDO after 15 fractions. Additional endpoints included SDO after 5 fractions and at the end of radiotherapy (EOT). Additional characteristics were analysed including use of smartphones/tablets, age, body mass index, performance score, comorbidity score, surgery, distress score, and emotional/ physical/practical problems. RESULTS: After 15 fractions, 38% of patients reported improvement of SDO (p<0.0001). Improvement rates were 22% after 5 fractions (p=0.003) and 39% at EOT (p<0.0001). Moreover, a significant association was observed for lower distress score after 5 fractions. CONCLUSION: Improvement of SDO occurred more often than expected, most likely due to habituation to radiotherapy. Since SDO did not improve in the majority of patients, timely psychological support should be offered to all patients.

A prospective interventional study investigating sleep disorders prior to and during adjuvant radiotherapy for breast cancer.

BACKGROUND: Most breast cancer patients with non-metastatic disease receive adjuvant local or loco-regional radiotherapy. To be scheduled for irradiation may cause distress and fears that can lead to sleep disorders. Few reports focused on sleep problems in patients assigned to radiotherapy. This study evaluates the course of sleep disorders during adjuvant radiotherapy for primary breast cancer and potential risk factors including the use of smartphones or tablets at bedtime. METHODS: The main goal is the evaluation of sleep disorders prior to radiotherapy and after 15 fractions of radiotherapy. A potential effect of habituation to the procedure of radiotherapy can be assumed that will likely lead to improvement (decrease) of sleep disorders. Improvement of sleep disorders (compared to baseline before radiotherapy) is defined as decrease of the severity of sleep disorders by ≥2 points on a patient self-rating scale (0 = no problems; 10 = maximum problems) or decrease of distress caused by sleep disorders by ≥2 points on a self-rating scale (0 = no distress; 10 = maximum distress) or reduction of the dose of sleeping drugs by ≥25%. Additional endpoints include sleep disorders after 5 fractions and at the end of radiotherapy. Moreover, potential risk factors including the use of smartphones or tablets at bedtime are evaluated. Fifty-one patients (48 plus potential drop-outs) are required. 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 improvement of sleep disorders is 25% (rate under the alternative hypothesis) and assuming that a decrease of ≤10% has to be judged as a random, non-causal change in this uncontrolled study setting (null hypothesis). DISCUSSION: If a decrease of sleep disorders during the course of radiotherapy is shown, this aspect should be included in the pre-radiotherapy consent discussion with the patients. Moreover, identification of additional risk factors will likely lead to earlier psychological support. If the use of smartphones or tablets at bedtime is a risk factor, patients should be advised to change this behavior. TRIAL REGISTRATION: clinicaltrials.gov (NCT04879264; URL: https://clinicaltrials.gov/show/NCT04879264 ); registered on 7th of May, 2021.

Emotional Problems Prior to Adjuvant Radiation Therapy for Breast Cancer.

BACKGROUND/AIM: Being scheduled for radiotherapy can cause emotional distress. This study aimed to identify risk factors in 338 patients assigned to radiotherapy for breast cancer. PATIENTS AND METHODS: Nineteen potential risk factors including the COVID-19 pandemic were investigated for associations with the six emotional problems included in the National Comprehensive Cancer Network Distress Thermometer. RESULTS: Worry and fears were significantly associated with age ≤60 years; sadness with age and Karnofsky performance score (KPS) <90; depression with KPS and Charlson Comorbidity Index ≥3; loss of interest with KPS. Trends were found for associations between sadness and additional breast cancer/DCIS, Charlson Index and chemotherapy; between depression and additional breast cancer/DCIS, treatment volume and nodal stage N1-3; between nervousness and additional breast cancer/DCIS, mastectomy and triple-negativity; between loss of interest and Charlson Index, family history of breast cancer/DCIS, invasive cancer, chemotherapy, and treatment volume. The COVID-19 pandemic did not increase emotional problems. CONCLUSION: Several risk factors for emotional problems were identified. Patients with such factors should receive psychological support well before radiotherapy.

Sleep Disorders Before and During the COVID-19 Pandemic in Patients Assigned to Adjuvant Radiotherapy for Breast Cancer.

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.

Sleep Disorders in Patients With Breast Cancer Prior to a Course of Radiotherapy - Prevalence and Risk Factors.

BACKGROUND/AIM: Most patients with breast cancer are assigned to radiotherapy, which may cause fears leading to sleep disorders. Very few data are available regarding the prevalence of sleep disorders and corresponding risk factors. PATIENTS AND METHODS: Data of 175 patients with breast cancer presenting for adjuvant radiotherapy were retrospectively analyzed. Twenty-three patient and tumor characteristics were investigated for associations with pre-radiotherapy sleep disorders. RESULTS: Seventy-eight patients (44.6%) stated sleep disorders prior to radiotherapy. These were significantly associated with higher distress score (p<0.0001); greater number of emotional (p<0.0001), physical (p<0.0001) or practical problems (p<0.001); and request for psycho-oncological support (p<0.001). Trends were found for worse performance status (p=0.062) and higher comorbidity index (p=0.059). CONCLUSION: Sleep disorders prior to radiotherapy for breast cancer are common. This applies particularly to patients with risk factors including distress due to emotional, physical or practical problems. These patients should be offered psycho-oncological support as soon as possible.

Accelerated Fractionation With Concomitant Boost vs. Conventional Radio-chemotherapy for Definitive Treatment of Locally Advanced Squamous Cell Carcinoma of the Head-and-Neck (SCCHN).

BACKGROUND/AIM: Patients with unresectable head-and-neck cancer (SCCHN) unable to tolerate radiochemotherapy may receive unconventionally fractionated radiotherapy. This retrospective study compared both treatments. PATIENTS AND METHODS: Eight patients unsuitable for chemotherapy were assigned to accelerated fractionation with concomitant boost (AF-CB, 69.6 Gy/39 fractions) over 5.5 weeks (group A) and 72 patients to cisplatin-based radiochemotherapy (70 Gy/35 fractions) over 7 weeks (group B). Groups were matched (cancer site, gender, age, performance score, T-/N-stage, histologic grade) and compared for loco-regional control (LRC), metastases-free survival (MFS), overall survival (OS) and toxicities. RESULTS: LRC, MFS, OS and radiation-related toxicities were not significantly different between groups A and B. Improved outcomes were associated with favorable cancer site, better performance score and T3-stage. In group B, toxicity led to reduction/discontinuation of chemotherapy in 38.9% and interruptions of radiotherapy >7 days in 19.3% of patients. CONCLUSION: AF-CB appeared a reasonable alternative for patients who cannot safely receive radio-chemotherapy for unresectable SCCHN.

Accelerated Fractionation Plus Chemotherapy Versus Conventionally Fractionated Radiochemotherapy for Unresectable Head-and-Neck Cancer.

BACKGROUND/AIM: Prognosis of patients with unresectable squamous cell carcinomas of the head and neck requires improvement. This retrospective study compared accelerated radiotherapy plus chemotherapy to conventional radiochemotherapy. PATIENTS AND METHODS: Patients received definitive treatment with accelerated radiotherapy plus chemotherapy (group A, n=10) or conventional cisplatin-based radiochemotherapy (group B, n=85). Groups were matched for several patient and tumor characteristics and compared for locoregional control (LRC), overall survival (OS) and toxicities. Additionally, accelerated radiotherapy plus chemotherapy and chemotherapy regimens in group B were compared for LRC and OS. RESULTS: Treatment type had no significant impact on LRC (p=0.98) and OS (p=0.57). In group A, toxicities occurred more often, including grade ≥3 mucositis (p=0.041), grade ≥2 lymphedema (p=0.007) and grade ≥3 leucopenia (p=0.007). Best 2-year LRC (p=0.39) and OS (p=0.015) was achieved with 20 mg/m2 cisplatin days 1-5 every 4 weeks; accelerated radiochemotherapy resulted in second-worst outcomes. CONCLUSION: Given the limitations of this study, accelerated radiotherapy plus chemotherapy provided no significant benefit but increased toxicity compared to conventional radiochemotherapy.

A randomized trial (RAREST-01) comparing Mepitel® Film and standard care for prevention of radiation dermatitis in patients irradiated for locally advanced squamous cell carcinoma of the head-and-neck (SCCHN).

Mepitel® Film (MEP) and standard care (STD) were compared for radiation dermatitis in SCCHN patients. This trial was stopped prematurely since13/28 patients did not tolerate MEP. Grade ≥2 dermatitis: 34.8% (MEP) vs. 35.7% (STD) at 50 Gy, 65.2% vs. 59.3% at 60 Gy. MEP was unsatisfactorily tolerated and appeared not superior (NCT03047174).