Treatment

No pharmacotherapies are currently approved by the FDA to treat OM, and no gold standard for treatment exists. Pain management is a priority. MASCC/ISOO guidelines recommend patient-controlled oral morphine to treat pain due to OM.2 Transdermal fentanyl, mouthwash containing 2% morphine, or mouthwash containing 0.5% doxepin are also suggested as possible treatments for OM pain.2 The guidelines recommend against use of a mouthwash containing sucralfate (a mucosal coating agent) to treat OM based on 20 studies that failed to show a beneficial effect.2 


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Over the past several years, a number of mucosal coating agents have received clearance from the FDA to be marketed as devices for the treatment of OM symptoms.2 Aquoral is a lipid-based spray designed to mimic saliva and is used to relieve dry mouth and its sequelae.24

There are no published studies of Aquoral in patients with OM related to anticcancer therapy.25 Caphosol (supersaturated calcium phosphate) is an oral rinse also designed to resemble human saliva and relieve dryness and pain from OM. Data from several recent studies published in peer-reviewed journals concluded Caphosol was ineffective at reducing the incidence or severity of OM in patients undergoing radiotherapy or myeloablative chemotherapy.26-29 NeutraSal contains the same active ingredient as Caphosol and is intended to relieve pain and dryness in patients with OM; no studies on NeutraSal have been published in peer reviewed journals.30

Several oral adhesive gels are available for patients with OM, including MuGard, Gelclair, GelX, Episil, and Mucotrol. Limited evidence is available to support their efficacy. Gelclair is a polyvinylpyrrolidone-sodium hyaluronate gel and is the oldest mucosal coating device cleared for OM. In a single-center observational study of Gelclair in patients with OM after HCST, 22 patients received Gelclair and 15 used standard oral rinses (ie, benzydamine, chlorhexidine, or saliva solutions).31

The study showed no difference between the Gelclair-treated patients and controls in pain intensity, but GelClair was associated with significantly longer pain relief (3 vs 1 h, P = .001).31 An open-label study evaluated Gelclair in 33 Australian HNC patients with OM secondary to radiotherapy.32 Prior to treatment, 88% were experienced severe pain. Patients received Gelclair for a median of 2 days. Pain scores declined from an average of 8.33 before Gelclair to 3.52 afterward.32

The only randomized, controlled trial of Gelclair evaluated its effect on pain over 24 hours in patients with radiotherapy-induced OM. The trial found no significant difference between Gelclair and standard therapy with sucralfate and mucaine.33

MuGard hydrogel was compared with sham treatment (a saline bicarbonate rinse) in a double-blind randomized trial that included patients with oral cancer who developed OM after radiotherapy and chemotherapy.34 MuGard was significantly more effective than the sham rinse at reducing mouth and throat soreness. None of the other differences in outcomes achieved statistical significance.34