Sumac-rose water mouthwash versus benzydamine to prevent radiation-induced oral mucositis in head and neck cancers: a phase II randomized trial.

BACKGROUND: Radiation-induced oral mucositis (OM) largely impairs the quality of life (QoL) of patients with head and neck cancer (HNC). Few choices with limited efficacy are available to prevent this adverse effect. This randomized trial was conducted to compare the efficacy of benzydamine (standard) and a new combination (sumac and rose water) in preventing radiation-induced OM. METHODS: This was a phase II, triple-blind, active-controlled, randomized trial. The primary endpoint was OM, and the secondary endpoints were oral pain and QoL. Besides, the possible variables defining the outcomes were analyzed using the chi-squared test (univariate analysis) and binomial regression model (multivariate analysis). RESULTS: Sumac-rose group had fewer high-grade OM (33% vs. 63%, odds ratio [OR] 0.28, 95% confidence interval [CI 95%] 0.08-0.93, P = 0.03) and better QoL (P < 0.05). Multivariate analysis confirmed these findings. Sumac-rose rinsing could also postpone the start of oral pain (hazard ratio [HR] 0.02, CI 95% 0.001-0.32, P = 0.001) and high-grade OM (HR 0.28, P = 0.03) compared with benzydamine. CONCLUSIONS: The sumac-rose group had a lower OM rate and grade and higher QoL than the benzydamine group. In addition, the experimental group developed high-grade OM and oral pain later during the radiotherapy course. Further studies need to be conducted to assess the role of sumac and rose water in reducing grade 3-4 mucositis in patients who undergo chemoradiation for head and neck cancer.

Low-Dose Whole-Lung Irradiation for COVID-19 Pneumonia: Final Results of a Pilot Study.

INTRODUCTION: Radiation therapy (RT), commonly used in cancer management, has been considered as one of the potential treatments for COVID-19 pneumonia. Here, we present the results of the pilot trial evaluating low-dose whole-lung irradiation (LD-WLI) in patients with COVID-19 pneumonia. METHODS: Ten patients with moderate COVID-19 pneumonia were treated with LD-WLI in a single fraction of 0.5 or 1.0 Gy along with the national protocol. The primary endpoint was an improvement in Spo2. The secondary endpoints were the number of days of hospital/intensive care unit stay, the number of intubations after RT, 28-day mortality, and changes in biomarkers. The response rate (RR) was defined as an increase in Spo2 upon RT with a rising or constant trend in the next 2 days, clinical recovery (CR) including patients who were discharged or acquired Spo2 ≥93% on room air, and 28-day mortality rate defined based on days of RT. RESULTS: The median age was 75 years (80% male). Five, 1, and 4 patients received single-dose 0.5 Gy, two-dose 0.5 Gy, and single-dose 1.0 Gy LD-WLI, respectively. The mean improvement in Spo2 at days 1 and 2 after RT was 2.4% (±4.8%) and 3.6% (±6.1%), respectively, with improvement in 9 patients after 1 day. Five, 1, and 4 patients were discharged, opted out of the trial, and died in the hospital, respectively. Two of 5 discharged patients died within 3 days at home. Among discharged patients, the Spo2 at discharge was 81% to 88% in 3 patients and 93% in the other 2 patients. Overall, the RR and CR were 63.6% and 55.5%, respectively. The RR, CR, and 28-day mortality of the single 0.5 Gy and 1.0 Gy WLI groups were 71.4% versus 50% (P = .57), 60% versus 50% (P = .64), and 50% versus 75% (P = .57), respectively. CONCLUSION: LD-WLI with a single fraction of 0.5 Gy or 1 Gy is feasible. A randomized trial with patients who do not receive radiation is required to assess the efficacy of LD-WLI for COVID-19.