Treatment of Severe Mucositis Pain With Oral Ketamine Mouthwash

NCT01566448 | Completed Phase 2 Results DMC

• 1 other identifier: WVU041011
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Mucositis

Keywords

Ketamine; Mucositis; Oral ketamine rinse

Outcome Measures

Primary Outcomes (1)

• Change in Pain Scores

  Change in pain score as reported at baseline and after the use of ketamine mouthwash on a numeric scale from 0 to 10, with 0 representing no pain and 10 representing the worst pain.

  1 hour after baseline

Secondary Outcomes (5)

• Time From Dose Administration to Change in Pain Intensity as Reported by Subject.

  1 day after start of ketamine mouthwashes

• Duration of Effect of Pain Reduction

  Day 1 after start of ketamine mouthwashes

• Change in Use of Narcotic Analgesics

  Days 1 after start of ketamine mouthwashes

• Change in Topical Lidocaine Usage

  Days 1 after start of ketamine mouthwashes

• Change in Sleep Quality

  Day 1 after start of ketamine mouthwashes

Study Arms (1)

Ketamine

EXPERIMENTAL

Ketamine oral mouthwash 20mg/5ml swish and spit four times daily

Drug: Ketamine

Interventions

Ketamine DRUG

20mg/5ml swish and spit four times daily

Ketamine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient has oral mucositis pain that is grade 3 or 4 according to the World Health Organization (WHO) Oral Mucositis Scale
• Patient has received at least one prior chemotherapy or radiation treatment
• Patient is at least 18 years old
• Patient or their legally authorized representative understands and voluntarily signs the written informed consent prior to any study-specific procedures. A copy of the signed informed consent form will be retained by the treating institution.

Sponsors & Collaborators

• Aaron Cumpston, PharmD, BCOP: lead

Study Sites (1)

West Virginia University Hospitals Mary Babb Randolph Cancer Center

Morgantown, West Virginia, 26506, United States

Location

Related Publications (10)

• 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.

  PMID: 18360600 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.

  PMID: 10650895 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.

  PMID: 15108222 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.

  PMID: 12183754 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.

  PMID: 18289497 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.

  PMID: 19703730 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.

  PMID: 12974832 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.

  PMID: 19708855 BACKGROUND

• 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.

  PMID: 28190158 DERIVED

Related Links

• West Virginia University Mary Babb Randolph Cancer Center

MeSH Terms

Conditions

Mucositis

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Aaron Cumpston
• Organization: West Virginia University Hospitals

cumpstona@wvumedicine.org

304-598-4000

Study Officials

• Aaron Cumpston, PharmD

  West Virginia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Pharmacy Clinical Specialist (Principal Investigator)

Study Record Dates

• First Submitted: March 27, 2012
• First Posted: March 29, 2012
• Study Start: February 1, 2012
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: April 27, 2022
• Results First Posted: January 11, 2021

Record last verified: 2022-04

Locations

US (1)