Treatment of Severe Mucositis Pain With Oral Ketamine Mouthwash

Summary

Oral mucositis (inflammation of the lining of the mouth) is a very common adverse effect when chemotherapy and radiation therapy are used to treat cancer. Mucositis occurs in about 40% of patients receiving standard dose chemotherapy, 80% of patients receiving radiation therapy of the head and neck, and up to 100% of patients undergoing a bone marrow transplant. Because the pain from mucositis can be so bad it can cause the inability to eat or drink, inability to talk, gagging and drooling. Many times mucositis can affect cancer treatment because patients may have to be given a lower dose of a drug or stop treatment completely. There are not many treatments today that can help relieve the severe pain caused from mucositis. This research study will help researchers determine if using an oral mouthwash called Ketamine will help lessen mucositis pain. Ketamine is approved by the Food and Drug Administration (FDA) for use with general anesthesia, sedation and for severe pain. WVU Hospital is now using Ketamine mouthwash as a standard treatment option for mucositis pain. During this study patients will be assessed to determine the level of pain caused by their mucositis. This will occur before the first dose, one hour after the first dose, and then daily until they are no longer on the study. Patients will use the mouthwash by swishing and spitting (20mg/5ml) four times each day, and also every four hours as needed. Patients will use the mouthwash on this study until their mucositis gets better or until the mucositis gets worse (or if the pain does not get better after three days of treatment).

Timeline

Start

2012-02

Primary completion

2015-07

Completion

2015-07

Publications

• Background Harris DJ. Cancer treatment-induced mucositis pain: strategies for assessment and management. Ther Clin Risk Manag. 2006 Sep;2(3):251-8. doi: 10.2147/tcrm.2006.2.3.251.
• Background Bellm LA, Epstein JB, Rose-Ped A, Martin P, Fuchs HJ. Patient reports of complications of bone marrow transplantation. Support Care Cancer. 2000 Jan;8(1):33-9. doi: 10.1007/s005209900095.
• Background Sonis ST, Elting LS, Keefe D, Peterson DE, Schubert M, Hauer-Jensen M, Bekele BN, Raber-Durlacher J, Donnelly JP, Rubenstein EB; Mucositis Study Section of the Multinational Association for Supportive Care in Cancer; International Society for Oral Oncology. Perspectives on cancer therapy-induced mucosal injury: pathogenesis, measurement, epidemiology, and consequences for patients. Cancer. 2004 May 1;100(9 Suppl):1995-2025. doi: 10.1002/cncr.20162.
• Background Borbasi S, Cameron K, Quested B, Olver I, To B, Evans D. More than a sore mouth: patients' experience of oral mucositis. Oncol Nurs Forum. 2002 Aug;29(7):1051-7. doi: 10.1188/02.ONF.1051-1057.
• Background Bensinger W, Schubert M, Ang KK, Brizel D, Brown E, Eilers JG, Elting L, Mittal BB, Schattner MA, Spielberger R, Treister NS, Trotti AM 3rd. NCCN Task Force Report. prevention and management of mucositis in cancer care. J Natl Compr Canc Netw. 2008 Jan;6 Suppl 1:S1-21; quiz S22-4.
• Background Ketamine. Clinical Pharmacology Online. Elsevier/Gold Standard, Inc. 15 Nov 2011.
• Background Finch PM, Knudsen L, Drummond PD. Reduction of allodynia in patients with complex regional pain syndrome: A double-blind placebo-controlled trial of topical ketamine. Pain. 2009 Nov;146(1-2):18-25. doi: 10.1016/j.pain.2009.05.017. Epub 2009 Aug 22.
• Background Slatkin NE, Rhiner M. Topical ketamine in the treatment of mucositis pain. Pain Med. 2003 Sep;4(3):298-303. doi: 10.1046/j.1526-4637.2003.03032.x.
• Background Ryan AJ, Lin F, Atayee RS. Ketamine mouthwash for mucositis pain. J Palliat Med. 2009 Nov;12(11):989-91. doi: 10.1089/jpm.2009.0198.
• Shillingburg A, Kanate AS, Hamadani M, Wen S, Craig M, Cumpston A. Treatment of severe mucositis pain with oral ketamine mouthwash. Support Care Cancer. 2017 Jul;25(7):2215-2219. doi: 10.1007/s00520-017-3627-6. Epub 2017 Feb 11.

Drugs

Indications