Jasminum grandiflorum oral gel as an add-on to standard of care in radiation induced grade 2 oral mucositis - an open label pilot clinical trial

Abstract

BackgroundRadiation-induced oral mucositis is one of the most critical dose-limiting toxicities associated with radiation therapy for oral cancer which can result in treatment interruption and compromise the quality of the life of cancer patients. Jati (Jasminum grandiflorum) is used in Ayurveda to treat oral conditions like stomatitis and mouth ulcers. ObjectiveTo test the feasibility of Jati oral gel as an add on therapy in grade 2 radiation-induced oral mucositis. Materials and methodsA prospective, open-label, non-randomised pilot trial was conducted on 20 patients with grade 2 radiation-induced oral mucositis at a tertiary cancer hospital. The control group received sodium bicarbonate mouthwash 4–5 times daily as the standard of care, while the intervention arm also received Jati oral gel twice daily. We used the ImageJ software for objective assessment and the Visual Analogue Scale for subjective pain assessment. The study was continued for 15 days or until the mucositis progressed to grade 3 or resolved to grade 1. ResultThere was a significant reduction in the mean pain score and mean area of mucositis in the intervention group compared to the control group. ConclusionJati oral gel is a suitable medicament as an add-on therapy in managing grade 2 radiation-induced oral mucositis.