Treatment of Severe Mucositis Pain With Oral Ketamine Mouthwash
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).
|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.
|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)|
Ketamine oral mouthwash 20mg/5ml swish and spit four times daily
20mg/5ml swish and spit four times daily
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01566448
|Contact: Pam Bunner, MTfirstname.lastname@example.org|
|Contact: Crystal Street, MTemail@example.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 firstname.lastname@example.org|
|Contact: Crystal Street, MT 304-598-4512 email@example.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|
|Principal Investigator:||Aaron Cumpston, PharmD||West Virginia University|