Evaluation of the efficacy of the anti-ulcer oral mucosal protective agent RADoralex® in the prevention and treatment of radiation-induced oral mucosal reactions induced during treatment of nasopharyngeal carcinoma

Abstract

The aim of this study was to evaluate the efficacy and safety of antiulcer oral mucosal protectant-RADoralex® in the prevention and treatment of radiation-induced oral mucosal reactions elicited during intensity-modulated radiation therapy (IMRT). for locally advanced nasopharyngeal carcinoma (NPC). A total of 90 patients with locally advanced NPC who developed post-treatment grade 1 oral mucositis were selected for this study. They were randomly assigned to the experimental group (n = 44) treated by mouth rinsing with the RADoralex® during radiochemotherapy and the control group (n = 43) treated by mouth rinsing with sodium bicarbonate solution, and the patients’ oral mucosal conditions, quality of life, weight change and oral pain levels were analyzed. The incidence of Common Terminology Criteria for Adverse Events (CTCAE) v4.0 grade 2 and grade 3 oral mucositis were significantly lower in the experimental group than in the control group. Compared to the control group, the time to progression, and the time from the end of treatment to oral mucosa healing in the experimental group was significantly shorter. The experimental group lost 8.66 ± 3.543% of their body weight during treatment period, while the control group lost 12.53 ± 4.284% ( p < .001). From the beginning the 3 rd week of treatment to the 2 nd week after the end of treatment, the Oral Mucositis Assessment Scale (OMAS) scores were lower in the experimental group than in the control group ( p < .05). RADoralex® significantly reduced the incidence and severity of oral mucositis in patients with locally advanced NPC during radiochemotherapy, delayed the progression of oral mucositis.

Management of Oral Hygiene in Head-Neck Cancer Patients Undergoing Oncological Surgery and Radiotherapy: A Systematic Review

“…Lozano et al [ 19 ] tested the efficacy of a high-dose (3%) melatonin mucoadhesive oral gel, demonstrating decreased incidence of severe mucositis and duration of ulcerative mucositis. Y. Jun et al [ 23 ] showed the efficacy of an antiulcer oral mucosal protectant mouthwash in the incidence and severity of radio-induced mucositis and in improving the quality of life.…”

“…Eight studies were judged at high risk of bias (M.J. Dodd (2022) [ 13 ]; N. Ebert et al (2021) [ 15 ]; M.H. Hamzah et al (2022) [ 18 ]; A. Lozano et al (2021) [ 19 ]; S. Shah et al (2020) [ 21 ]; Y. Jun et al (2022) [ 23 ]; O. Apperley et al (2017) [ 28 ]; A. Lam-ubol et al (2021) [ 29 ]; H.O. Sohn et al (2018) [ 35 ]).…”

Update on the treatment of chemotherapy and radiotherapy- induced buccal mucositis: a systematic review

“…A total 287 articles were retrieved, of which 86 were selected by title and abstract and 18 were finally included after full-text analysis [15][16][17][18][19][20][21][22][23][24][25][26][27][28][29][30][31][32] . The selection process is detailed in Fig.…”

The effect of early oral nutritional supplements on improving nutritional outcomes and radiation‐induced oral mucositis for nasopharyngeal carcinoma patients undergoing concurrent chemoradiotherapy

“…Studies have found that LANPC patients who received radical radiotherapy and developed RIOM had an average healing time of approximately 34.67 ± 15.02 days. 31 Therefore, delaying ONS intervention until obvious RIOM symptoms occur may be too late, because ongoing RIOM can interfere with the efficacy of ONS, and inadequate ONS may disrupt normal cell and tissue metabolism, and impede the repair of radiation damage. Persistent RIOM can further decrease food intake, aggravate weight loss, and trigger severe malnutrition, creating a vicious cycle.…”

“…As a result, repair of the oral mucosa requires a relatively long time. Studies have found that LANPC patients who received radical radiotherapy and developed RIOM had an average healing time of approximately 34.67 ± 15.02 days 31 . Therefore, delaying ONS intervention until obvious RIOM symptoms occur may be too late, because ongoing RIOM can interfere with the efficacy of ONS, and inadequate ONS may disrupt normal cell and tissue metabolism, and impede the repair of radiation damage.…”