Effect of Bio Adhesive Barrier-Forming Oral Liquid on Oral Mucositis Severity and Duration in a Clinical Setting With Concurrent Chemo-Radiation for Patients With Head and Neck Cancer

Abstract

<h3>Purpose/Objective(s)</h3> Oral mucositis is the most common and debilitating complication in patients undergoing radiotherapy and chemotherapy for squamous cell carcinoma of the head and neck (SCCHN). 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. Despite the significant detrimental sequelae associated, there is no consensus on the optimum oral care regimen even though different strategies have been put forward to prevent severe 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 concurrent chemo-radiation in a clinical setting <h3>Materials/Methods</h3> Twenty-five patients with Head and Neck cancer proven histopathologically, were enrolled for the study. Patients were required to have symptomatic oral mucositis (RTOG Grade 2 or above) at screening and pain scores of at least 6 on an 11-point Likert scale at screening and on each day before radiotherapy. Patients were administered bio adhesive oral spray 3 times per day from week 4 to week 6 during radiation therapy and oral mucositis pain was assessed in terms of severity and duration over the following 8 hours <h3>Results</h3> During screening, 73% of patients had Grade III and 27% had Grade II Oral mucositis. After treatment, Patients experienced a median 50% decrease in pain intensity up to 1 hour. Treatment resulted in significant pain relief within 5 minutes of application that was evident during the entire 8-hour assessment period. The median pain intensity score reached 3 on Likert scale at 5 minutes following oral application and was maintained till 1 hour (i.e., patients experienced an average 4-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 course of the treatment period. None of the patients used opioids as rescue medication. Only 3 patients (12%) had the necessity for Nasogastric tube. Mean difference in weight loss during the treatment ranged from 0.7kg to1.6kg. The oral spray was safe and well tolerated by all patients <h3>Conclusion</h3> The bio adhesive barrier-forming oral liquid is efficacious in reducing pain in patients with oral mucositis undergoing chemo-radiation for head-and-neck cancer and demonstrated its potential value in clinical application. 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.