Treatment of Severe Mucositis Pain With Oral Ketamine Mouthwash

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by West Virginia University
Sponsor:
Information provided by (Responsible Party):
Aaron Cumpston, PharmD, West Virginia University
ClinicalTrials.gov Identifier:
NCT01566448
First received: March 27, 2012
Last updated: January 6, 2014
Last verified: January 2014
  Purpose

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
Mucositis
Drug: Ketamine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Daily narcotic analgesic use will be recorded.

  • Reduction in topical lidocaine usage [ Time Frame: Days 1, 2 and 3 after start of ketamine mouthwashes ] [ Designated as safety issue: No ]
    Daily topical lidocaine usage will be recorded.

  • Quality of life [ Time Frame: Days 1, 2 and 3 after start of ketamine mouthwashes ] [ Designated as safety issue: No ]
    Sleep quality, as reported by the subject on a numeric scale, and food intake will be used as surrogate markers of quality of life.


Estimated Enrollment: 30
Study Start Date: February 2012
Estimated Study Completion Date: September 2015
Estimated 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01566448

Contacts
Contact: Pam Bunner, MT 304-598-4511 bunnerp@wvuhealthcare.com
Contact: Crystal Street, MT 304-598-4512 streetc@wvuhealthcare.com

Locations
United States, West Virginia
West Virginia University Hospitals Mary Babb Randolph Cancer Center Recruiting
Morgantown, West Virginia, United States, 26506
Contact: Pam Bunner, MT    304-598-4511    bunnerp@wvuhealthcare.com   
Contact: Crystal Street, MT    304-598-4512    streetc@wvuhealthcare.com   
Principal Investigator: Alex Shillingburg, PharmD         
Sub-Investigator: Michael Newtown, PharmD         
Sub-Investigator: Michael Craig, MD         
Sub-Investigator: William Tse, MD         
Sub-Investigator: Soumit Basu, MD, PhD         
Sub-Investigator: Abraham Kanate, MD         
Sponsors and Collaborators
Aaron Cumpston, PharmD
Investigators
Principal Investigator: Aaron Cumpston, PharmD West Virginia University
  More Information

Additional Information:
Publications:

Responsible Party: Aaron Cumpston, PharmD, Pharmacy Clinical Specialist (Principal Investigator), West Virginia University
ClinicalTrials.gov Identifier: NCT01566448     History of Changes
Other Study ID Numbers: WVU041011
Study First Received: March 27, 2012
Last Updated: January 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by West Virginia University:
Ketamine
Mucositis
Oral ketamine rinse

Additional relevant MeSH terms:
Mucositis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases
Ketamine
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on July 29, 2014