Application

Oral lozenges (and other oral therapies) for the maintenance of oral health and treatment of mucositis associated with chemotherapy/radiation treatment.

Key Benefits

• Current approaches to the treatment of mucositis associated with cancer therapy have not proven to be efficacious.
• An over the counter (OTC) supplement involving glutathione, an antioxidant, reduced mucositis symptoms by 70% in an animal model.

Technical Summary

Mucositis (inflammation of the oral mucosa) is a common, painful, and often dose-limiting side effect associated with chemotherapy and/or radiation therapy for cancer and is especially common in patients with head and neck cancer. Approximately 1.5 million people are diagnosed with cancer in the United States each year and for most cancer treatments, about 5-15% of patients develop mucositis. In grade 3 oral mucositis, the patient is unable to eat solid food, and in grade 4, the patient is unable to consume liquids as well. Treating mucositis often requires a combination of hospitalization, narcotics and intravenous feeding. Current management of mucositis (also known as stomatitis) includes anti-inflammatory agents, steroids, mouthwash coating agents, antimicrobial therapy, and OTC nutritional supplements. However, none of these approaches has been proven to be efficacious and there is considerable variation in response between individuals. There is a need for novel approaches to prevent and treat mucositis.

Emory investigators have developed a novel supplement for treating mucositis and inflammation within the digestive tract involving glutathione, a major body antioxidant. Glutathione is critical to many metabolic and biochemical reactions, including cellular protection and repair, protein and DNA synthesis, prostaglandin synthesis, amino acid transport, and enzyme activation. Thus, every system in the body can be affected by the state of the glutathione system, especially the immune system. A unique combination of the glutathione and the pyrimidine synthesis intermediate orotate effectively treated mucositis in felines and canines. Within 2 weeks, inflammatory signs were greatly reduced in over 70% of the animals.

Developmental Stage

• Proof of concept demonstrated in animal models.
• Product palatability confirmed in a pilot study of glutathione-containing lozenges in head and neck cancer patients undergoing radiation therapy.