Efficacy and safety of transdermal fentanyl for the treatment of oral mucositis pain caused by chemoradiotherapy in patients with esophageal squamous cell carcinoma.

PURPOSE: Oral mucositis is one of the most painful side effects found in esophageal squamous cell carcinoma (ESCC) patients treated with chemoradiotherapy. The transdermal route of administration is worthy of investigation for patients who suffer from dysphagia due to severe oral mucositis. In this phase 2 study, we investigated the efficacy and safety of transdermal fentanyl (TDF) for mucositis pain caused by chemoradiotherapy in ESCC patients.
METHODS: Forty-six ESCC patients who experienced moderate to severe oral mucosal pain during chemoradiotherapy received TDF for pain relief. The assessment of pain was made according to the Numeric Rating Scale (NRS). Efficacy and safety of TDF was collected and conducted in an open-label fashion. The analgesic effect, quality of life, and side effects were evaluated after the administration of transdermal fentanyl using the paired sample Wilcoxon signed rank test.
RESULTS: The mucositis-induced pain disappeared in 31 (67.4 %) patients during the treatment with transdermal fentanyl with the median time of onset at day 6.6 (range 3-14). The median Numeric Rating Scale (NRS) score was reduced from 6 (range 3-9) before treatment to 4.5 (range 2-9), 3 (range 2-8), 2.5 (range 1-8), 2 (range 0-6), and 0 (range 0-4) on days 3, 6, 9, 11, and 15, respectively, after treatment (P < 0.001). The patients' quality of life also improved significantly (P < 0.01). The side effects of treatment were mild and disappeared within several days.
CONCLUSION: Transdermal fentanyl is an effective, convenient, and well-tolerated treatment for mucositis pain caused by chemoradiotherapy, which can improve ESCC patients' quality of life.