Study protocol for efficacy and safety of steroid-containing mouthwash to prevent chemotherapy-induced stomatitis in women with breast cancer: a multicentre, open-label, randomised phase 2 study

Abstract

IntroductionStomatitis is a frequent adverse event in patients undergoing chemotherapy for breast cancer. Stomatitis can hamper oral nutrition resulting in malnutrition, reduce quality of life and introduce the need for dose reductions and interruption of chemotherapy; however, there is currently no standard approach for preventing chemotherapy-induced stomatitis. We aimed to assess the safety and efficacy of a dexamethasone-based elixir mouthwash for preventing chemotherapy-induced stomatitis in patients with early breast cancer.Methods and analysisIn this multicenter, randomised, controlled phase 2 trial, we will randomly assign 120 women with early breast cancer undergoing chemotherapy to use of a dexamethasone-based elixir or standard oral care, to compare their preventive effects on chemotherapy-induced stomatitis. Patients will be assigned in a 1:1 ratio. Patients in the intervention group will receive chemotherapy, oral care and a dexamethasone-based elixir (10 mL 0.1 mg/mL; swish for 2 min and spit, four times daily for 9 weeks), and patients in the control group will receive chemotherapy and oral care. The primary endpoint is the difference in incidence of stomatitis between the two groups. The sample size allows for the detection of a minimum difference of 20% in the incidence of stomatitis between the two groups. Secondary endpoints are severity of stomatitis, duration of stomatitis, completion rate of chemotherapy and adverse events.Ethics and disseminationAll participants signed a written consent form, and the study protocol has been reviewed and approved by the Clinical Research Review Board of Nagasaki University (CRB7180001).Trial registration numberUMIN Clinical Trials Registry (UMIN000030489).

Effect of melatonin on quality of life and symptoms in patients with cancer: a systematic review and meta-analysis of randomised controlled trials

“… 72 Stomatitis, especially the grade 3 or 4 mucositis, 73 can hamper oral nutrition, resulting in malnutrition, reduce QoL and introduce the need for dose reductions and interruption of chemotherapy. 74 MLT has potential direct antitumour activity and has been proven to modulate the effects of cancer chemotherapy by enhancing therapeutic efficacy and reducing toxicity. 75 Our review showed that MLT had no effect on mucositis.…”

“…Oral mucositis refers to inflammation and ulceration of the oral mucosa, which is a frequent side effect of cancer therapy 72. Stomatitis, especially the grade 3 or 4 mucositis,73 can hamper oral nutrition, resulting in malnutrition, reduce QoL and introduce the need for dose reductions and interruption of chemotherapy 74. MLT has potential direct antitumour activity and has been proven to modulate the effects of cancer chemotherapy by enhancing therapeutic efficacy and reducing toxicity 75.…”