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Topical dexamethasone mouthwash reduces oral mucositis severity in head and neck cancer radiotherapy patientsCan a simple mouthwash prevent the painful mouth sores of cancer radiation?

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Key Takeaway
Consider topical dexamethasone mouthwash promising but unconfirmed for preventing radiation mucositis in HNC.

A phase II randomized controlled trial evaluated prophylactic topical dexamethasone oral solution (0.5 mg/10 mL gargled four times daily) versus placebo mouthwash in 50 patients with non-metastatic head and neck squamous cell carcinoma scheduled to receive ≥60 Gy radiotherapy. The primary outcome was incidence and maximum severity of oral mucositis during radiotherapy using WHO and NCI-CTCAE v.5 criteria.

Dexamethasone significantly reduced mucositis severity at all time points (all p < 0.01), though absolute numbers were not reported. Peak severity occurred later (week 5 vs week 3 with placebo). Patient-reported pain scores were lower from weeks 4-7 (median VAS 0-3 vs 4-6, p < 0.01). At 2 months, dysphagia was less frequent (32% vs 72%, p = 0.01). No grade 4 mucositis occurred in the dexamethasone arm versus 2 events in placebo.

No signal of treatment-related systemic steroid toxicity or increased oral infections was observed, and topical dexamethasone was well tolerated. Four patients discontinued (reasons in Results), with no statistically significant difference in discontinuation between arms.

Key limitations include the need for confirmation in larger multicenter trials with longer follow-up, formal patient-reported outcomes, and comparison with guideline-recommended strategies like photobiomodulation. As a phase II study, these findings are promising but preliminary; they cannot infer long-term effects, compare to standard of care, or generalize beyond the study population without further validation.

Imagine the pain of severe mouth sores making it impossible to eat or drink during cancer treatment. That's radiation-induced oral mucositis, a common and debilitating side effect for people getting radiation for head and neck cancer. A small, early-stage trial tested whether a simple preventive measure—rinsing with a steroid mouthwash—could help.

The study involved 50 patients who were scheduled for intensive radiation. Half used a mouthwash containing the steroid dexamethasone four times a day, while the other half used a placebo. The results were encouraging: those using the steroid rinse developed less severe mouth sores overall. Their pain scores were lower from weeks four through seven, and the peak severity of their sores was delayed by about two weeks. Notably, no one in the steroid group developed the most severe grade of mucositis, while two people in the placebo group did. The mouthwash was well-tolerated, with no sign of increased oral infections or systemic steroid side effects.

It's important to view these findings as a promising first step, not a final answer. This was a phase II study with only 50 patients, so the results need to be confirmed in much larger, longer trials. The researchers also note they didn't compare the mouthwash to other recommended strategies, like special light therapy. We don't yet know about any long-term effects. For now, this offers a hopeful glimpse at a potential new tool to ease a major source of suffering during cancer treatment.

What this means for you:
A steroid mouthwash may reduce pain and severity of radiation mouth sores, but larger studies are needed.

Study Details

Study typeRct
Sample sizen = 1
EvidenceLevel 2
Follow-up2.0 mo
PublishedApr 2026
View Original Abstract ↓
PURPOSE: Radiation-induced oral mucositis is a frequent and debilitating complication of curative radiotherapy for head and neck cancer. This randomized, triple-blind, placebo-controlled, parallel-group trial evaluated whether a topical dexamethasone oral solution (0.5 mg/10 mL) used as a prophylactic mouthwash reduces the incidence and severity of radiation-induced oral mucositis. METHODS: Fifty-four patients with non-metastatic head and neck squamous cell carcinoma scheduled to receive ≥ 60 Gy radiotherapy were randomized 1:1 to dexamethasone mouthwash or placebo and instructed to gargle 10 mL four times daily during radiotherapy. The primary endpoint was the incidence and maximum severity of oral mucositis occurring during radiotherapy, defined as the highest grade recorded using the WHO Oral Toxicity Scale and NCI-CTCAE criteria v. 5. Secondary endpoints included patient-reported pain (VAS), dysphagia, treatment discontinuation, and mucositis status at 2 months. Fifty patients completed the study (25 per arm); four patients discontinued (reasons reported in Results). RESULTS: The dexamethasone group had significantly lower mucositis severity at all time points by WHO and CTCAE scales (all p < 0.01), a delayed peak severity (week 5 vs week 3), lower pain scores from weeks 4-7 (median VAS 0-3 versus 4-6; p < 0.01), and lower dysphagia at 2 months (32% vs 72%; p = 0.01). No grade 4 mucositis occurred in the dexamethasone arm; two grade 4 events occurred in placebo. There were no statistically significant differences in treatment discontinuation. Topical dexamethasone was well tolerated; no signal of treatment-related systemic steroid toxicity or increased oral infections was observed. CONCLUSION: In this phase II study, prophylactic topical dexamethasone mouthwash reduced the severity and delayed the onset of radiation-induced oral mucositis and improved patient-reported pain. These findings are promising but require confirmation in larger multicenter trials with longer follow-up and formal patient-reported outcomes (e.g., EORTC QLQ-H&N35, OMAS) and comparison with guideline-recommended strategies such as photobiomodulation. TRIAL REGISTRATION NUMBER: Iranian Registry of Clinical Trials; trial registration number: IRCT20240525061893N1; date of registration: 21 July 2024.
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