Abstract 2072P
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 2nd 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 4thweek (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.
Resources from the same session
2045P - Patient Reported Outcome Measures (PROMs) capturing therapy adherence of cancer patients: A systematic literature review
Presenter: Luise Richter
Session: Poster session 06
2046P - The importance of communicating bad news in medical education
Presenter: Georgios Goumas
Session: Poster session 06
2047P - Neutrop: A descriptive, observational study for G-CSF prescription in daily practice
Presenter: Florian Scotté
Session: Poster session 06
2048P - Frequency and clinical relevance of drug-drug interactions with oxycodone among patients with cancer
Presenter: Lotte Hulskotte
Session: Poster session 06
2049P - Osimertinib-related muscle cramps as a common adverse event: A real-world data analysis in the post-approval setting
Presenter: Gisele Moreira
Session: Poster session 06
2050P - Integrating ayurveda herbs with standard of care for management of cancer or cancer treatment related anorexia
Presenter: Yogesh Bendale
Session: Poster session 06
2051P - E-PRO within comprehensive companion program for patients undergoing systemic cancer treatment to reduce emergency visits and inpatient admission in a Peruvian institution
Presenter: Patricia Rioja Viera
Session: Poster session 06
2052P - Adverse events in FLOT chemotherapy for locally advanced gastric cancer: An observational study of pre- and post-operative toxicity profiles
Presenter: Camila Oliveira
Session: Poster session 06
2053P - Dehospitalization through outpatient drug release in clinical pharmacy as a strategic cost-minimization action in a public oncology hospital in the Eastern Amazon: A quantitative analysis
Presenter: Kalysta Borges
Session: Poster session 06
2054P - Metastatic cancer patients hospitalized at initial diagnosis: When does rescue systemic therapy make sense? ONIRIS - A national, prospective study
Presenter: Colin Vercueil
Session: Poster session 06