Benzydamine vs Supersaturated Calcium Phosphate Oral Rinses for Radiation Induced Oral Mucositis in Head and Neck Cancer Patients.

Overview

The goal of this clinical trial is to compare and correlate salivary macrophage migratory inhibitory factor levels with onset and severity of radiation induced mucositis in head and neck cancer patients by using super saturated calcium phosphate solution and benzydamine hydrochloride oral rinses. Participants are patients of head and neck cancers undergoing radiation therapy of either gender. participants are divided into two groups Group A: Benzydamine group Group B: Super saturated calcium phosphate group * Participants will be using Oral rinses of their respective group and will be assessed for radiation induced oral mucositis at weekly intervals during radiation treatment. * salivary Macrophage migratory inhibitory factor levels will be assessed through ELISA, before and after the radiation treatment as per protocol.

42 patients of either gender and age group 30-70 years with head and neck cancer will be selected. Informed consent will be obtained from all the patients (Annex-I, Annex-II). Selected patients will have no history of previous radiotherapy or any other major systemic disease. There will be no evidence of oral mucositis before the commencement of study. The patients will be assigned into two groups by non-probability convenient sampling and their study groups will be as follows: Groups Number of patients Oral Rinse to be Used A 21 Benzydamine Hydrochloride B 21 Super saturated calcium phosphate solution Patients will be examined before starting radiotherapy. Radiation therapy will be started at a dose of 2 Gray per fraction for 5 days a week up to a total dose of 50-70 Grays in total 6 weeks. In the experimental group1patients will be asked to rinse with 15 ml benzydamine hydrochloride solution for three times daily from the day radiation therapy will start till the radiation therapy continues (6 weeks). In the experimental group 2 patients will be asked to rinse with 30 ml supersaturated calcium phosphate solution for four times daily from the day radiation therapy will start till the radiation therapy continues (6 weeks).supersaturated calcium phosphate solution will be prepared and dispensed(Annex III). It will be stored at room temperature. Examination of oral mucosa will be performed on all patients at the beginning of treatment and will be continued weekly up to the end of radiotherapy (6 weeks) by visual assessment. Grade 0-4 of oral mucositis by WHO will be assessed using battery operated light. Whole saliva sample will be collected from each participant of both the groups before the commencement of radiotherapy. Participants will rinse their mouth and then 3mL of whole saliva will be collected in disposable test tubes. Samples will be refrigerated at -80°c until ELISA is performed to quantify MIF levels. Saliva sample will also be collected after 3 weeks of end of radiotherapy and will be stored following the same protocol. MIF quantification will be done by sandwich ELISA method (BioLegend® Legend Max TM Human Active MIF, Cat. No. 438408) according to manufacturer's instructions. Grade 0: No change in oral mucosa. Grade 1 (Mild): Only mucosal erythema, no ulcers, oral/gingival mucosa is red and shiny. Gingiva may appear swollen. Grade 2 (Moderate): Erythema plus focal ulceratiaons, able to eat and drink. Grade 3 (Severe): Confluent ulcers, can take liquid diet only. Grade 4 (Un acceptable): Massive ulcers, unable to eat and drink. Study Variables Qualitative variable: • Onset and Severity/progression of Oral Mucositis WHO scale for grading oral mucositis (Cheng and Yeun., 2006) Grade 0: No change in oral mucosa. Grade 1 (Mild): Only mucosal erythema, no ulcers, oral/gingival mucosa is red and shiny. Gingiva may appear swollen. Grade 2 (Moderate): Erythema plus focal ulceratiaons, able to eat and drink. Grade 3 (Severe): Confluent ulcers, can take liquid diet only. Grade 4 (Un acceptable): Massive ulcers, unable to eat and drink. Statistical Analysis The data will be entered and analyzed using SPSS25 (full form). Normality of data will be calculated by Shapiro Wilk test. The quantitative data will be analyzed using Student-T test to determine the mean difference in quantitative variables between groups. Mean ± SD will be given for quantitative variable (ELISA macrophage migratory inhibitory factor levels). Chi square test will be used for analysis of qualitative variable (The onset and severity of oral mucositis). A p- value of ≤ to 0.05 will be considered significant.