Alexandra Shillingburg1,2, Abraham S Kanate3, Mehdi Hamadani4, Sijin Wen5, Michael Craig3, Aaron Cumpston6,3. 1. Department of Pharmacy, West Virginia University Medicine, P.O. Box 8045, Medical Center Drive, Morgantown, WV, 26506, USA. shillingburga@wvumedicine.org. 2. Osborn Hematopoietic Malignancy and Transplantation Program, West Virginia University Cancer Institute, Morgantown, WV, USA. shillingburga@wvumedicine.org. 3. Osborn Hematopoietic Malignancy and Transplantation Program, West Virginia University Cancer Institute, Morgantown, WV, USA. 4. Division of Hematology/Oncology, Medical College of Wisconsin, Milwaukee, WI, USA. 5. Department of Biostatistics, West Virginia University Cancer Institute, Morgantown, WV, USA. 6. Department of Pharmacy, West Virginia University Medicine, P.O. Box 8045, Medical Center Drive, Morgantown, WV, 26506, USA.
Abstract
PURPOSE: Mucositis is a significant complication of intensive chemotherapy or hematopoietic cell transplantation (HCT), with few treatment options. Ketamine mouthwashes have been used for pain relief, but supporting evidence is limited. The primary objective of this study was to assess the reduction in pain intensity of stomatodynia and odynophagia compared to baseline assessment. METHODS: This open-label, prospective, phase II interventional study (NCT01566448) was conducted from February 2012 through July 2015. Patients with grade 3 or 4 oral mucositis according to the World Health Organization (WHO) scale as a result of chemotherapy were treated with ketamine mouthwash 20 mg/5 mL four times daily and every 4 h as needed. RESULTS: Thirty patients were enrolled and a total of 136 assessments were conducted. A statistically significant reduction in pain scores of 2 and 3 points was achieved after 1 h and 3 days, respectively (p < 0.0001, p = 0.0003). Pain scores were significantly improved while swallowing, reduced 1 and 4 points at 1-h and 3-day assessment, respectively (p = 0.0006, p = 0.0001). No patients developed adverse effects related to ketamine administration. CONCLUSION: Ketamine mouthwashes resulted in clinically meaningful and statistically significant reduction in pain scores, have an acceptable safety profile, and can be a useful adjunctive treatment in the multi-modal management of severe mucositis.
PURPOSE:Mucositis is a significant complication of intensive chemotherapy or hematopoietic cell transplantation (HCT), with few treatment options. Ketamine mouthwashes have been used for pain relief, but supporting evidence is limited. The primary objective of this study was to assess the reduction in pain intensity of stomatodynia and odynophagia compared to baseline assessment. METHODS: This open-label, prospective, phase II interventional study (NCT01566448) was conducted from February 2012 through July 2015. Patients with grade 3 or 4 oral mucositis according to the World Health Organization (WHO) scale as a result of chemotherapy were treated with ketamine mouthwash 20 mg/5 mL four times daily and every 4 h as needed. RESULTS: Thirty patients were enrolled and a total of 136 assessments were conducted. A statistically significant reduction in pain scores of 2 and 3 points was achieved after 1 h and 3 days, respectively (p < 0.0001, p = 0.0003). Pain scores were significantly improved while swallowing, reduced 1 and 4 points at 1-h and 3-day assessment, respectively (p = 0.0006, p = 0.0001). No patients developed adverse effects related to ketamine administration. CONCLUSION: Ketamine mouthwashes resulted in clinically meaningful and statistically significant reduction in pain scores, have an acceptable safety profile, and can be a useful adjunctive treatment in the multi-modal management of severe mucositis.
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