Phase 2
N=30
Treatment of Severe Mucositis Pain With Oral Ketamine Mouthwash
Mucositis
Bottom Line
View on ClinicalTrials.gov: NCT01566448 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcome: Primary: Change in Pain Scores — 2 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ketamine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Aaron Cumpston, PharmD, BCOP
- Primary completion
- Jul 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Pain Scores |
2 | — |
| SECONDARY Time From Dose Administration to Change in Pain Intensity as Reported by Subject. |
2; 28 | — |
| SECONDARY Duration of Effect of Pain Reduction |
14; 7; 6; 0; 1; 2 | — |
| SECONDARY Change in Use of Narcotic Analgesics |
12 | — |
| SECONDARY Change in Topical Lidocaine Usage |
1 | — |
| SECONDARY Change in Sleep Quality |
1 | — |
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).
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01566448). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.