Abstract
BackgroundOral mucositis (OM) associated with cancer treatment not only impairs patients’ quality of life but also causes treatment delays or changes. This prospective exploratory study was conducted to evaluate the efficacy of Episil® oral liquid, which is an approved protective formulation for the oral mucosa in patients with OM. The extent of the pain-relieving effect, feeling during use, and adverse events or problems were evaluated.MethodsIn total, 10 Japanese cancer patients with OM receiving chemotherapy, pretreatment therapy for hematopoietic stem cell transplantation, or radiation therapy for head and neck cancer were enrolled.ResultsA numerical rating scale (NRS) was used to assess oral pain intensity due to OM. Compared to baseline, the mean NRS began to decrease at 5 min after using Episil® (7.1 ± 1.4 to 4.6 ± 2.87; p = 0.264). A significant decrease was observed in the pain score after using Episil® compared with that before using Episil®, and this effect lasted up to 120 min. The protective effects of Episil® were observed 3–5 min after application. Some patients felt slight soreness or discomfort when applying Episil®. However, this discomfort due to Episil®’s stimulation was within the allowable range and transient. No adverse events were observed in any of the cases.ConclusionsThe results of this prospective study showed that Episil® could be an effective treatment to relieve oral pain in Japanese patients with moderate to severe OM, and this newly approved product might adequately support patients’ oral intake.Trial registrationUniversity Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR) (UMIN000031921).
Highlights
Oral mucositis (OM) associated with cancer treatment impairs patients’ quality of life and causes treatment delays or changes
The Multinational Association of Supportive Care in Cancer [8], National Comprehensive Cancer Network [9], and European Society for Medical Oncology [10] have provided some recommendations for the management of mucositis, the use of benzydamine, photo-bio-modulation, zinc, and glutamine intake [8] is not covered under the Japanese social insurance system
Nine patients had Grade 2, and one patient had Grade 3 OM according to the NCI-CTCAE Version3.0
Summary
Oral mucositis (OM) associated with cancer treatment impairs patients’ quality of life and causes treatment delays or changes. Unrelenting oral pain due to severe OM causes subsequent inability to eat and drink, leading to secondary malnutrition and dehydration Prolonging this condition makes patients’ performance status poorer and potentially interrupts cancer treatments [3, 11, 12]. Non-steroidal anti-inflammatory drugs (NSAIDs), opioids, and local analgesic therapies have been reported to be effective in this patient population [8] They do not always eliminate oral pain because they are generally ineffective against breakthrough pain caused by swallowing or food contact with ulcerative mucositis lesions
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