Presented at ASCO 2026, this multicenter randomized phase II trial evaluated topical betamethasone ointment for preventing severe chemoradiotherapy-induced oral mucositis in patients with head and neck cancer.
The study was led by Sakiko Soutome from the Center for Clinical and Translational Research, Toyama University Hospital, Toyama, Japan.
Background
Severe oral mucositis remains one of the most difficult toxicities during cisplatin-based chemoradiotherapy for head and neck cancer. It can affect nutrition, pain control, treatment adherence, and overall quality of life.
Although topical dexamethasone has shown some benefit during radiotherapy alone, its role during concurrent chemoradiotherapy has been limited. This trial investigated whether a more potent topical corticosteroid, betamethasone ointment, could reduce severe oral mucositis during cisplatin-based CRT.
Study Design
Patients with head and neck cancer receiving chemoradiotherapy with the oral cavity included in the radiation field were enrolled across six institutions in Japan. After developing grade 1 oral mucositis, patients were randomized to receive either standard oral care alone or standard oral care plus topical betamethasone ointment applied three times daily. Treatment continued until completion of radiotherapy or the development of grade 3 oral mucositis. The primary endpoint was time to grade 3 oral mucositis. Secondary endpoints included time to grade 2 or 3 oral mucositis and the incidence of oral candidiasis.
Key Results
A total of 68 patients were analyzed, including 35 in the betamethasone group and 33 in the control group. The cumulative incidence of grade 3 oral mucositis was substantially lower with betamethasone compared with standard oral care alone: 14.3% versus 48.5%. Topical betamethasone significantly reduced the risk of grade 3 oral mucositis, with a hazard ratio of 0.246. It also delayed the onset of grade 2 or 3 oral mucositis. nImportantly, betamethasone did not increase oral candidiasis. Denture use, rather than betamethasone, was identified as a significant risk factor for candidiasis.
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Why This Matters
This study addresses a very practical and clinically important problem in head and neck cancer care. Severe oral mucositis is common during cisplatin-based chemoradiotherapy and can be difficult to prevent.
The intervention tested here is simple, low-cost, and widely accessible. If confirmed in larger studies, topical betamethasone could become an easily implementable supportive care strategy to reduce treatment-related toxicity and improve patient comfort during chemoradiotherapy.
Conclusion
In this randomized phase II trial, topical betamethasone ointment significantly reduced severe oral mucositis during cisplatin-based chemoradiotherapy for head and neck cancer, without increasing oral candidiasis.
These findings suggest a promising, practical supportive care approach for managing one of the most challenging toxicities of head and neck chemoradiotherapy.