Abstract
BackgroundOral mucositis frequently occurs in cancer patients treated with chemotherapy and chemoradiotherapy (CRT). This study examined the safety and efficacy of ibuprofen gargle in healthy volunteers and patients with chemotherapy- and concomitant CRT-induced oral mucositis.MethodsWe enrolled healthy volunteers and patients with chemotherapy- and CRT-induced oral mucositis. In cohort I, single and multiple doses of ibuprofen gargle (0.6% or 1.0%) were administered to healthy volunteers on day 1 and days 4–10. In cohort II, multiple doses of ibuprofen gargle (0.6%) were administered to patients with complicated grade 2–3 oral mucositis based on the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The primary endpoint of cohort I was the treatment-related adverse events (TRAEs) as defined by CTCAE version 4.0. The primary endpoint of cohort II was the change in the visual analogue scale (VAS) pain score from before to 15 min after gargle use on day 3. The incidence and severity of TRAEs were assessed based on the CTCAE version 4.0 and a subjective rating scale completed by healthy volunteers and patients.ResultsIn cohort I, 9 of 10 healthy volunteers were evaluable for safety. All 9 healthy volunteers reported the TRAE of oral irritation with single or multiple use of the gargle. In cohort II, 10 patients were enrolled and evaluable for safety and 7 of 10 patients were evaluable for efficacy. The mean change in the VAS pain score from before to 15 min after using the gargle on day 3 was − 1.28 (95% confidence interval: − 2.06, − 0.51), and all patients experienced some degree of pain relief (range: − 0.2 to − 2.5). All 10 patients reported the TRAE of oral irritation. No other TRAEs of ibuprofen gargle were observed in the healthy volunteers and patients.ConclusionDespite oral irritation, the ibuprofen gargle appeared to be safe and effective for the pain related to chemo- or CRT-induced oral mucositis. However, ibuprofen-related oral irritation warrants further formulation improvement.Trial registrationThis study was registered with the University Hospital Medical Information Network Clinical Trials Registry (UMIN000014433).
Highlights
Oral mucositis frequently occurs in cancer patients treated with chemotherapy and chemoradiotherapy (CRT)
We investigated the safety of ibuprofen gargle in healthy volunteers, and the safety and efficacy in patients with chemotherapy- and CRT-induced oral mucositis
A randomized crossover study reported that the 2% morphine mouthwash for the World Health Organization (WHO) grade ≥ 2 mucositis led to a decrease in the mean visual analogue scale (VAS) pain score on day 3 compared with placebo [4]
Summary
Oral mucositis frequently occurs in cancer patients treated with chemotherapy and chemoradiotherapy (CRT). Oral mucositis frequently occurs in patients with cancer treated with chemotherapy, chemoradiotherapy (CRT), or haematopoietic stem cell transplantation [1, 2]. The mucositis makes it difficult to chew, maintain oral hygiene, and sustain adequate nutrition, causing impaired quality of life and the potential for stopping treatment [2, 3]. In the clinical practice guidelines for the use of anti-inflammatory agents in the prevention and/or treatment of oral mucositis, the evidence supports the use of benzyldamine mouthwash only is the recommendation and suggestion for the prevention of mucositis associated with radiotherapy and CRT, respectively [2]. Additional well-designed research is needed for the treatment of oral mucositis pain in cancer patients
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