Birla Institute Of Technology, Mesra,Mesra,Jharkhand,Ranchi-835215
CO-Principal Investigator
Dr. Ashok Kumar Pattnaik
Birla Institute Of Technology, Mesra,Mesra,Jharkhand,Ranchi-835215
Project Overview
Oral mucositis (OM) is defined as erythematous and ulcerative lesions of the oral mucosa. It is among the clinically important and common side effects caused by chemotherapy and radiation therapy in cancer patients. These complications may limit the patient's ability to tolerate an optimal antineoplastic treatment, which can negatively impact treatment planning and prognosis. It is therefore critical that mucositis can be prevented or treated to improve the overall care of patients with cancer. In recent years, extensive research has been conducted to determine the effectiveness of a vast number of diverse interventions for the prevention or treatment of OM in cancer patients. In spite of current recommendations and suggestions for OM management, there is still a gap in the scientific evidence regarding standard treatment. The antioxidant, analgesic, anti‐inflammatory, antiseptic, antimicrobial, and anti-carcinogenic effects of turmeric and curcumin, a polyphenol extracted from its rhizome, have been described in literature. Microorganisms play an important role in the ulceration stage and have been found correlated with the progression of OM in recent studies. Probiotics are living microorganisms that provide health benefits to the host when administered in sufficient numbers. In recent years, the use of probiotics in cancer care related fields have gained increasing attention because of their possible benefits in the prevention of cancer therapy induced toxic side effects, including diarrhea and oral mucositis. This study is proposed to develop and characterize a Microencapsulated Streptococcus salivariusK12-curcumin gel for prevention or treatment of Oral mucositis in post radiation oral cancer patient. The methodology will include formulation of microencapsulated gel product. The formulation of product includes different steps Growth of Microorganisms Streptococcus salivarius K12 in Brain Heart Infusion agar, Curcumin extraction, Fabrication of Streptococcus salivarius K12-curcumin fusion alginate micro particle, Formulation of microparticle powder, Formulation of microencapsulated Gel. The physical characterization evaluation and skin irritation testing will be done. The prepared gel will be tested on animal model, and will be evaluated for its safety and efficacy followed by Phase I and Phase II human trial. Phase I will include healthy individual to assess its safety, tolerability, site reaction and adverse effect and Phase II will include patients of oral cancer on radiotherapy to evaluate the efficacy of microencapsulated gel in prevention and treatment of Oral mucositis.