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Treatment of Severe Mucositis Pain With Oral Ketamine Mouthwash

This study has been completed.
Information provided by (Responsible Party):
Aaron Cumpston, PharmD, West Virginia University Identifier:
First received: March 27, 2012
Last updated: December 11, 2015
Last verified: December 2015

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).

Condition Intervention Phase
Drug: Ketamine
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Severe Mucositis Pain With Oral Ketamine Mouthwash

Resource links provided by NLM:

Further study details as provided by West Virginia University:

Primary Outcome Measures:
  • Reduction in pain scores [ Time Frame: 1 hour, 1 day, 2 days and 3 days after start of ketamine mouthwashes ]
    Reduction in pain score as reported after use of ketamine mouthwash on a numeric scale compared to a baseline assessment.

Secondary Outcome Measures:
  • Patient reported tolerability of mouthwashes due to taste and irritation [ Time Frame: 1 hour, 1 day, 2 days and 3 days after start of ketamine mouthwashes ]
    Patients will be questioned regarding tolerability of mouthwashes due to taste and irritation.

  • Assess the time from dose administration to reduction in pain intensity as reported by subject. [ Time Frame: 1 hour, 1 day, 2 days and 3 days after start of ketamine mouthwashes ]
    Patients will be questioned about time until maximal pain relief and given options of: no effect, 1-15 minutes, 15-30 minutes, 30-45 minutes, 45-60 minutes and greater than 1 hour.

  • Duration of effect of pain reduction [ Time Frame: Days 1, 2, and 3 after start of ketamine mouthwashes ]
    Patients will be question about the duration of pain relief and given the option of no effect, less than one hour, 1-2 hours, 2-3 hours, 3-4 hours, greater than 4 hours or N/A.

  • Reduction in use of narcotic analgesics [ Time Frame: Days 1, 2 and 3 after start of ketamine mouthwashes ]
    Daily narcotic analgesic use will be recorded.

  • Reduction in topical lidocaine usage [ Time Frame: Days 1, 2 and 3 after start of ketamine mouthwashes ]
    Daily topical lidocaine usage will be recorded.

  • Quality of life [ Time Frame: Days 1, 2 and 3 after start of ketamine mouthwashes ]
    Sleep quality, as reported by the subject on a numeric scale, and food intake will be used as surrogate markers of quality of life.

Enrollment: 30
Study Start Date: February 2012
Study Completion Date: July 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ketamine
Ketamine oral mouthwash 20mg/5ml swish and spit four times daily
Drug: Ketamine
20mg/5ml swish and spit four times daily

  Show Detailed Description


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01566448

United States, West Virginia
West Virginia University Hospitals Mary Babb Randolph Cancer Center
Morgantown, West Virginia, United States, 26506
Sponsors and Collaborators
Aaron Cumpston, PharmD
Principal Investigator: Aaron Cumpston, PharmD West Virginia University
  More Information

Additional Information:
Ketamine. Clinical Pharmacology Online. Elsevier/Gold Standard, Inc. 15 Nov 2011.

Responsible Party: Aaron Cumpston, PharmD, Pharmacy Clinical Specialist (Principal Investigator), West Virginia University Identifier: NCT01566448     History of Changes
Other Study ID Numbers: WVU041011
Study First Received: March 27, 2012
Last Updated: December 11, 2015

Keywords provided by West Virginia University:
Oral ketamine rinse

Additional relevant MeSH terms:
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action processed this record on April 28, 2017