2072P - Topical application of mixed agents to reduce oral mucositis during radiotherapy in post operated head and neck cancer

Background

Oral mucositis is a debilitating condition seen in head and neck cancer(HNC) patients treated by radiotherapy(RT). The aim of study was to evaluate the response of combined new oral agents as local applicant to prevent mucositisand to record the change in mucositis grading during and after RT.

Methods

Sixty threepatients of post-operative HNC planned for adjuvantRT were randomized to treat mucositis by soda bicarbonate gargles only (Control arm: n=30) 4-5 times a day or soda bicarbonate gargle along with new agent comprised of five drugs (ORA-5GEL): one tablespoon each of honey, choline salicylate ointment(8.7w/w), and lignocaine ointment(2%w/w), one tablet of fluconazole 150mg and metronidazole 400mg were mixed to form a paste and applied intraorally starting from 2^nd week of RT (Study arm:n=33).

Results

Severity of mucositis was found to be either stable or in downgrading trend after the application of the ORA-5 gel. None of the patients had grade3 mucositis in study arm compared to 15 patients in control arm. Grade 1 mucositis was seen in 64% and 97% of patients at the end of week 3 that progressed to grade 2 in 27% and 70% patients study and control arm, respectively, by the end of 4^thweek (p<0.001). On univariate analysis, factors associated with higher mucositis grading were: high disease burden (Stage IV), conventional RT technique and concurrent chemotherapy. In study arm reversible trend of grading was observed in this subset of patients also. With the continuous use of soda bicarbonate gargle and symptomatic treatment, the frequency of grade 3 mucositis in control arm decreased, however, there was significant difference in grading in both the groups till week 7(p<0.001). By the end of the treatment, none of the patients in control arm had grade 0 mucositis compared to 73% in study arm.

Conclusions

ORA-5 GEL effectively acts on all stages of mucositis and prevents not only severity and progression in all patients but also shows reversible grading during RT.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

C. Prakash.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.