Cosmetic Dermatology and Hair Care

Statement of the Problem: Oropharyngeal mucositis (OM) and Oral mucositis is an adversity of chemo- and radio-therapy and is accompanied by severe throat and oral pain in patients with CTCAE grades of over 3, which includes 30% of cancer patients treated with radio-therapy. OM often impairs quality of life (QOL) and leads to discontinuation of chemo- and radio-therapy because severe pain compromises oral intake and nutritional status. In this study, we tried to use the Indomethacin oral spray (IM-OS) preparation to relief the pain that induced cancer therapy. Methods: We observed 35 patients (male/female: 20/15, 53 ± 17 y) with oropharyngeal mucositis, who treated with IM-OS preparation for pain relief at University of Tsukuba hospital, Japan. Analgesic effects were assessed using the six-grade face scale for pain in 28 patients at the start of IM oral spray treatment. Systemic exposure was assessed by determining urinary excretions of IM in seven patients. Results: Pain relief was achieved in 26 (93%) patients at 25 (5–60) min after applying the IM-OS preparation (15.6 ± 3.4 μg/kg) and analgesic effects were maintained for 120 (10–360) min. The pain was significantly decreased after using the spray (3.6 ± 0.7 vs. 2.4 ± 0.9, p < 0.01). Moreover, urinary IM excretion rates after applying the IM spray preparation were 1.8 ± 0.8% of the IM oral spray dose (130.5 ± 77.7 μg/kg/day), which was markedly lower than that following oral administration of IM (60%). No adverse events were observed following application of the spray. Conclusions: The present IM spray is an effective and safe for pain relief and can be used as an alternative therapeutic option for oropharyngeal mucositis in cancer patients.