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 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).