Combination of Hyaluronic Acid, Chondroitin Sulphate, and Poloxamer 407 for the Prevention and Treatment of Radiation Esophagitis (Results of the RESOXX Multicenter Prospective Observational Study)

Aim: to evaluate the efficacy of an oral medical device — a fixed combination of hyaluronic acid, chondroitin sulphate, and the bioadhesive agent poloxamer 407 (Alfasoxx), on the incidence, course, and severity of radiation esophagitis symptoms in patients undergoing external beam radiotherapy for a primary malignancy.Materials and methods. A total of 215 patients were enrolled in the study, of whom 210 were included in the statistical analysis. Patients were divided into two groups: a treatment group (patients with manifestations of radiation esophagitis at study entry) and a prophylaxis group (patients enrolled on the start date of external beam radiotherapy). Seventeen oncologists from nine Russian cities participated in the study. Assessment methods included clinical and demographic evaluation, analysis of the incidence and distribution of radiation esophagitis risk factors, evaluation of radiation esophagitis severity according to CTCAE v. 5.0, assessment of radiation dose delivered to the esophagus, Alfasoxx dosage accounting for compliance, evaluation of the time to radiation esophagitis onset and its duration, analysis of swallowing function using the EAT-10 questionnaire, assessment of overall health-related quality of life using the EORTC QLQ-C30 questionnaire, and monitoring of adverse events.Results. Manifestations of radiation esophagitis were observed in 68.5 % of patients in the prophylaxis group; therefore, radiation esophagitis did not develop in 31.5 % of patients. Compared with the prophylaxis group, patients in the treatment group experienced a more severe course of the disease, with a mean radiation esophagitis severity score of 0.83 ± 0.53 vs. 0.52 ± 0.25 (p < 0.001). The mean EAT-10 score at baseline differed from that in the treatment group. However, from Visit 2 onward, mean scores aligned and demonstrated identical dynamics. A similar distribution was observed for overall quality of life as assessed by the EORTC QLQ-C30 questionnaire. The significant difference observed at the first visit (68.73 ± 15.69 points in the prophylaxis group vs. 58.24 ± 16.04 points in the treatment group; p < 0.001) was leveled by Visit 4 among patients who developed radiation esophagitis (79.96 ± 10.91 points in the prophylaxis group and 81.25 ± 11.03 points in the treatment group). Only one adverse event was identified during Alfasoxx administration: mild nausea after intake.Conclusion. The prophylactic administration of Alfazox concurrently with the initiation of external beam radiotherapy reduces the mean severity of radiation-induced esophagitis and shortens the duration of symptom manifestation.