Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01566448 · ClinicalTrials.gov registry record · Phase 2
Treatment of Severe Mucositis Pain With Oral Ketamine Mouthwash
A Phase 2 study, sponsored by Aaron Cumpston, PharmD, BCOP.
- Completed
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
NCT01566448 is a Phase 2 study that has completed, run by Aaron Cumpston, PharmD, BCOP. The registered enrollment target is 30 participants.
The verdict
NCT01566448, a Phase 2 study, has completed, sponsored by Aaron Cumpston, PharmD, BCOP.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
Study 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).
Interventions
- DRUG Ketamine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2012-02 |
| Est. Completion | 2015-07 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01566448
The ClinicalTrials.gov registry entry for NCT01566448 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Aaron Cumpston, PharmD, BCOP, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Ketamine is the first listed.
NCT01566448 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01566448 about?
NCT01566448 is a clinical study titled "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,...
What is the current status of trial NCT01566448?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2012-02. Estimated completion is 2015-07.
What interventions are being tested in trial NCT01566448?
The interventions under investigation include: Ketamine (DRUG).
Who is sponsoring clinical trial NCT01566448?
This trial is sponsored by Aaron Cumpston, PharmD, BCOP, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.