![]() ![]() have shown significant anesthetic and analgesic properties of doxepin in patients with OM. Two non-randomized, open-label trials by Epstein et al. °includes an optional continuation phase. 14 In recent pilot trials, doxepin has been shown to reduce the frequency and severity of OM complications in cancer patients. 12, 13 Doxepin, an antidepressant, has recently been shown to produce temporary local anesthesia, followed by more durable analgesia when used topically. 4, 10-12 Topical analgesics such as lidocaine, benzocaine, and diphenhydramine usually reduce pain for up to 30 min, though contact with the ulcerated layer of oral mucosa often causes stinging and taste impairment. 9 Widely used treatment options include antimicrobial rinses, mucosal coating agents, and systemic and topical anesthetics and analgesics, which often include opioid derivatives. There is no uniform management for OM, though various standards currently exist. ![]() Furthermore, OM may interrupt scheduling and dosing for cancer therapy, which compromises treatment efficacy. The open sores resulting from OM pose an increased risk for infection. 1, 2 OM and its associated pain can deter patients from eating and subsequently deplete their nutritional intake, which may eventually lead to hospitalization. 5 Usually occurring within 14 days after the start of external beam RT, OM is an acute toxicity which can rapidly diminish a patient’s quality of life. 1, 4 Radiobiologically, the oral mucosa is an early responding tissue for RT and shares a similarly high α–β ratio compared with the head and neck tumor itself. 1, 4 Erythema and pain caused by OM, which manifests as traumatized ulcers within the oral cavity and oropharynx, can occur due to rapid mucosal breakdown as a result of RT. 1-3 A significant majority of head and neck cancer patients treated with radiation, with or without chemotherapy, experience painful oral mucositis (OM). While the use of radiotherapy (RT) in the treatment of various solid cancers has become increasingly effective due to technological innovations, numerous acute and chronic treatment-related adverse effects impact the patients’ quality of life. Doxepin may represent a new standard for treating RT-induced OM pain in the future. ![]() Doxepin will also be further compared with magic mouthwash and a placebo solution in a three-arm trial (Miller and Sio et al.) with head and neck cancer patients with OM pain caused by RT. Currently, a placebo-controlled study (Sio and Miller et al.) using doxepin for esophagitis pain caused by RT to the thorax is underway. Doxepin, a traditional tricyclic antidepressant with analgesic and anesthetic properties when applied topically to the mucosa, has been shown to lower OM pain in multiple single-arm trials (Epstein et al.) and more recently, in a placebo-controlled crossover study (Leenstra and Miller et al.). Conventionally, RT-induced OM pain is treated with analgesics and/or mouthwash rinses. Pain from OM can impact a patient’s quality of life and interrupt RT treatment schedules, which decreases the probability for achieving cancer cure. Radiotherapy (RT), an integral part of the oncologic treatment for patients with head and neck cancer, can cause adverse side effects such as oral mucositis (OM). ![]()
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