Treatment of Severe Mucositis Pain With Oral Ketamine Mouthwash
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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 |
- 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.
- 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 Primary Completion Date: | July 2013 (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 |
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| Contact: Pam Bunner, MT | 304-598-4511 | bunnerp@wvuhealthcare.com |
| Contact: Crystal Street, MT | 304-598-4512 | streetc@wvuhealthcare.com |
| 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: Mehdi Hamadani, MD | |
| Sub-Investigator: William Tse, MD | |
| Sub-Investigator: Soumit Basu, MD, PhD | |
| 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 11, 2013 |
| 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 May 19, 2013