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Oral mucositis is the debilitating complication in patients undergoing radical radiotherapy with or without chemotherapy for squamous cell carcinoma of the head and neck. It is one of the major acute morbidities causing pain and dysphagia leading to treatment breaks and hospitalization which has a major impact on prognosis and treatment outcome. Despite the significant detrimental sequelae associated, there is no consensus on the optimum oral care regimen to prevent severe oral mucositis. This study was conducted to evaluate the effect of bio adhesive lipid barrier on oral mucosa, which acts as a mechanical barrier for the treatment of oral mucositis in patients with head-and-neck cancer undergoing radical radiotherapy with or without chemotherapy in a clinical setting.

Twenty-five patients with Head and Neck cancer proven histopathologically, after obtaining informed written consent were enrolled for the study. At screening, patients were required to have symptomatic oral mucositis (RTOG Grade 2 or above) and oral pain scores of at least 6 on an 11-point Likert scale at screening and each day before radiotherapy. Patients were administered bioadhesive oral spray three times a day and oral mucositis pain, dysphagia, and odynophagia were assessed in terms of severity and duration at 5 minutes,30 minutes,1,2,4, and 6 hours.

During the screening, 64% of patients had Grade III and 36% had Grade II Oral mucositis. After treatment, Patients experienced a median 57.1% decrease in pain intensity immediately within 5 minutes lasting up to 30 minutes and 42.9% up to 2 hours. The median pain intensity score reached 3 points on Likert scale at 5 minutes following oral spray application and was maintained up to 1 hour (i.e., patients experienced an average 3-point decline in pain intensity from baseline to 1 hour after treatment).

Regarding rescue medication, only paracetamol was used in a total of 2 patients (8 %) during the treatment period. Opioids were not used as a rescue medication in any of the patients. Only 3 patients (12%) had the necessity for the Nasogastric tube. Dysphagia improved in 22 patients (88%) from semisolids to solids consumption within 5 minutes and lasted up to 6 hours in 7 patients (28%) with p<0.05 at end of 6 hours. Whereas, odynophagia reduced within 5 minutes in 22 patients (88%) and lasted up to 4 hours in 6 patients (24) with p<0.05 at end of 4 hours. The mean difference in weight loss during the treatment ranged from 0.7kg to1.6kg.

The bioadhesive barrier-forming oral liquid is efficacious in reducing pain in patients with oral mucositis undergoing radical radiotherapy with or without chemotherapy for head-and-neck cancer and demonstrated its potential value in clinical application. The analgesic effect was immediate, clinically significant, and persisted for up to 6 hours. It is well tolerated and the trend towards less Nasogastric tube-dependency and a possible reduction in In-patient time is promising.