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No agent has yet been approved by the US Food and Drug Administration (FDA) for preventing OM in patients with head and neck cancers. The only FDA-approved preventive agent for OM in other cancers is the human recombinant keratinocyte growth factor palifermin (produced by E coli bacteria), which stimulates mucosal cell growth and has been approved for patients with hematologic cancers who undergo total body irradiation for autologous stem cell transplantation.1 Agents that have undergone clinical study but for which the evidence was insufficient to recommend their use in preventing or treating OM have included antibacterial lozenges and mouth rinses, misoprostol, granulocyte-colony stimulation factor.1
Several phase 3 clinical trials are under way in the United States, France, and China, including studies of the immunomodulating innate defense regulator dusquetide (ClinicalTrials.gov Identifier: NCT03237325), the anti-inflammatory protease inhibitor ulinastatin (ClinicalTrials.gov Identifier: NCT03387774), and the antioxidant superoxide dismutase mimetic GC4419 (ClinicalTrials.gov Identifier: NCT03689712).1 Dusquetide is believed to reduce inflammatory pathway signaling. In a phase 2 clinical trial, patients with locally advanced head and neck cancer undergoing concurrent cisplatin chemoradiotherapy saw a 50% reduction in duration of severe OM following dusquetide administration, compared to patients who were administered placebo.1,4 In preclinical animal studies, low-level laser therapy (LLLT) has exhibited anti-inflammatory and wound healing effects and in human patients, pretreating patients with LLLT before they underwent cisplatin concurrent chemoradiation was associated with reduced OM severity.1 However, LLLT’s safety has not been demonstrated and its effects on cancer cells has not been assessed.1
Although chewing gum, jaw exercises, and passive range of motion devices are widely utilized treatment strategies for RIT, the evidence base for these interventions remains equivocal. A recent study assessing 2 exercise interventions intended to reduce mouth opening among radiotherapy patients with head and neck cancers failed to demonstrate any benefit.2 In fact, exercise regimens might backfire; the study authors cautioned that exercises intended to reduce RIT severity could actually worsen patients’ pain.2
References
1. Blakaj A, Bonomi M, Gamez ME, Blakaj DM. Oral mucositis in head and neck cancer: evidence-based management and review of clinical trial data. Oral Oncol. 2019;95:29-34.
2. Bragante KC, Groisman S, Carboni C, et al. Efficacy of exercise therapy during radiotherapy to prevent reduction in mouth opening in patients with head and neck cancer: a randomized controlled trial. Oral Surg Oral Med Oral Pathol Oral Radiol. 2020;129:27-38.
3. Lalla R, Bowen J, Barasch A, et al. MASCC/ISOO clinical practice guidelines for the management of mucositis secondary to cancer therapy. Cancer. 2014;120:1453-1461.
4. Kudrimoti M, Curtis A, Azawi S, et al. Dusquetide: a novel innate defense regulator demonstrating a significant and consistent reduction in the duration of oral mucositis in preclinical data and a randomized, placebo-controlled phase 2a clinical study. J Biotechnol. 2016;239;115-125.
