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Treatment of Severe Mucositis Pain With Oral Ketamine Mouthwash

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01566448
Recruitment Status : Completed
First Posted : March 29, 2012
Results First Posted : January 11, 2021
Last Update Posted : January 11, 2021
Information provided by (Responsible Party):
Aaron Cumpston, PharmD, BCOP, West Virginia University

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).

Condition or disease Intervention/treatment Phase
Mucositis Drug: Ketamine Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Severe Mucositis Pain With Oral Ketamine Mouthwash
Study Start Date : February 2012
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
Experimental: Ketamine
Ketamine oral mouthwash 20mg/5ml swish and spit four times daily
Drug: Ketamine
20mg/5ml swish and spit four times daily

Primary Outcome Measures :
  1. Change in Pain Scores [ Time Frame: 1 hour after baseline ]
    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.

Secondary Outcome Measures :
  1. Time From Dose Administration to Change in Pain Intensity as Reported by Subject. [ Time Frame: 1 day 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.

  2. Duration of Effect of Pain Reduction [ Time Frame: Day 1 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.

  3. Change in Use of Narcotic Analgesics [ Time Frame: Days 1 after start of ketamine mouthwashes ]
    Change in IV morphine equivalents of opioid requirements

  4. Change in Topical Lidocaine Usage [ Time Frame: Days 1 after start of ketamine mouthwashes ]
    Change of topical lidocaine uses in 24 hour period

  5. Change in Sleep Quality [ Time Frame: Day 1 after start of ketamine mouthwashes ]
    Sleep quality, as reported by the subject on a numeric scale (1-10) will be used as a surrogate marker of quality of life with 0 indicating no sleep and 10 indicating the best sleep you have had.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01566448

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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, BCOP
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Principal Investigator: Aaron Cumpston, PharmD West Virginia University
Additional Information:
Ketamine. Clinical Pharmacology Online. Elsevier/Gold Standard, Inc. 15 Nov 2011.

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Aaron Cumpston, PharmD, BCOP, Pharmacy Clinical Specialist (Principal Investigator), West Virginia University Identifier: NCT01566448    
Other Study ID Numbers: WVU041011
First Posted: March 29, 2012    Key Record Dates
Results First Posted: January 11, 2021
Last Update Posted: January 11, 2021
Last Verified: December 2020
Keywords provided by Aaron Cumpston, PharmD, BCOP, West Virginia University:
Oral ketamine rinse
Additional relevant MeSH terms:
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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