Preventing Mouth Sores Caused by Head and Neck Cancer Treatments with Melatoin Gel

Oral mucositis is the name for mouth sores, head and neck cancer treatments, chemotherapy and radiotherapy, having these as their most prominent side effect. Oral mucositis is almost inevitable with radiotherapy, which is highly effective against head and neck cancers. Yet no effective method has been found to prevent it or treat it after development. For oral mucositis prevention , melatonin oral gelwas tested in the MUCOMEL phase-2 clinical trial, one of the noteworthy topics at the ASCO 2018 Congress.
Melatonin is a hormone mainly secreted in our bodies by the pituitary gland, an extension of the brain. Outside the pituitary, it is secreted by the gastrointestinal system, skin and respiratory epithelial cells. The functions of melatoninare to protect cells by controlling harmful intracellular substances (oxidative stress) and inflammation .
Radiotherapy and chemotherapy are known to disrupt the melatoninergic system of the mucosa lining the mouth, respiratory tract and digestive tract.
Based on this knowledge, scientists thought a melatonin oral gel called Mucomel could prevent mucosal damage due to radiotherapy and/or chemoradiotherapy. They conducted a trial of high-dose %3 melatonin gel involving 79 patients.
Patients with stage 3 and 4 squamous head and neck carcinoma were enrolled and randomized into two arms: 40 patients received gel 5 times daily at 10 ml (gargled and then swallowed), while 39 received placebo oral gel.
At the end of the study, melatonin gel was found to significantly reduce severe oral mucositis in patients receiving the standard head and neck cancer chemotherapy cisplatin , with grade 3 and 4 mucositis reduced significantly. No side-effect difference from placebo was observed. Melatonin also reduced the need for painkillers and nutritional support and shortened hospital stays.
In conclusion , melatonin oral gel reduced severe oral mucositis incidence and duration, painkiller and additional nutrition requirements, and hospital stay in cisplatin-treated head and neck cancer patients. If confirmed by a larger phase-3 trial, these results could introduce a new treatment into clinical practice that meaningfully helps with this serious side effect.
Sources
Phase II trial of high-dose melatonin oral gel for the prevention and treatment of oral mucositis in H&N cancer patients undergoing chemoradiation (MUCOMEL).
2018 ASCO Annual Meeting - Abstract No: 6007
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