Journal of cancer research and therapeutics · 2021
Safety and efficacy of Oro-T oral rinse in oral mucositis during cancer radiotherapy and/or chemotherapy: Cumulative analysis of two studies.
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Koushik Kirthi, Janaki M G, Kumawat Rajesh, Paramesh Rangesh, Palaniyamma D
Аннотация
INTRODUCTION: Oral mucositis is inflammation of the mucosa of the mouth which ranges from redness to severe ulceration. It results from the local effects of radiation to the oral mucosa.
OBJECTIVES: The study is cumulative analysis of two studies (one comparative and the other open labeled) evaluated in individuals with oral mucositis during cancer radiotherapy and/or chemotherapy for the safety and efficacy of Oro-T mouthwash in a comparative design with normal saline.
METHODOLOGY: Both the studies were similar with respect to clinical and laboratory parameters for analysis. The participants were advised to use 10 ml of Oro-T for 1 min 4 times daily for 6 weeks starting from day 1 of standard care. Patients were followed up, and the results were assessed from baseline on visit days: At entry and at the end of every week for 6 weeks. Clinical assessment of oral condition was done objectively (by the investigator) and also subjectively. Clinical symptoms such as sore throat, number of ulcer, burning sensation, pain, difficulty in chewing, difficulty in drinking, and mucositis grading along with Patient Reported Outcome Measures Scale were evaluated at each interval. Data was available for 40 subjects in Oro-T and 15 subjects in NS groups respectively.
RESULTS AND CONCLUSION: The significant positive outcome was reported both subjectively and objectively in Oro-T group as compared to NS group with the delay in the onset of symptoms and less severe manifestation of oral mucositis with an improvement in quality of life. No adverse effects were reported that prompted discontinuation of study medication. Overall compliance to study medication was good.
OBJECTIVES: The study is cumulative analysis of two studies (one comparative and the other open labeled) evaluated in individuals with oral mucositis during cancer radiotherapy and/or chemotherapy for the safety and efficacy of Oro-T mouthwash in a comparative design with normal saline.
METHODOLOGY: Both the studies were similar with respect to clinical and laboratory parameters for analysis. The participants were advised to use 10 ml of Oro-T for 1 min 4 times daily for 6 weeks starting from day 1 of standard care. Patients were followed up, and the results were assessed from baseline on visit days: At entry and at the end of every week for 6 weeks. Clinical assessment of oral condition was done objectively (by the investigator) and also subjectively. Clinical symptoms such as sore throat, number of ulcer, burning sensation, pain, difficulty in chewing, difficulty in drinking, and mucositis grading along with Patient Reported Outcome Measures Scale were evaluated at each interval. Data was available for 40 subjects in Oro-T and 15 subjects in NS groups respectively.
RESULTS AND CONCLUSION: The significant positive outcome was reported both subjectively and objectively in Oro-T group as compared to NS group with the delay in the onset of symptoms and less severe manifestation of oral mucositis with an improvement in quality of life. No adverse effects were reported that prompted discontinuation of study medication. Overall compliance to study medication was good.