Clinical Trial: Treatment of Severe Mucositis Pain With Oral Ketamine Mouthwash

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Treatment of Severe Mucositis Pain With Oral Ketamine Mouthwash

Brief 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).


Detailed Summary:

Mucositis

Mucositis is an adverse effect as a result of chemotherapy and radiation treatments and has significant quality of life and clinical consequences. Mucositis is a result of direct cytotoxic damage as well as a cytokine-mediated inflammatory response and can affect the epithelial mucosal surfaces along the entire gastrointestinal tract. Mucositis manifesting in the oral cavity can be especially distressing to patients and may involve erythema, cracking, inflammation, bleeding and ulceration and typically begins 5-10 days after starting chemotherapy. Mucositis occurs in about 40% of patients receiving standard dose chemotherapy, 80% of patients receiving radiation therapy to the head and neck, and up to 100% of patients undergoing a bone marrow transplant.(1)

Pain from oral mucositis has been reported as the single most debilitating side effect by patients receiving bone marrow transplants. Mucositis is also the most common condition requiring analgesics during cancer therapy. Complications of pain from mucositis include inability to tolerate food or fluid intake, difficulty or inability to talk, excess mucus, gagging, sleep disturbances, and drooling. Mucositis may also require hospital admission or extended admission for total parenteral nutrition, intravenous analgesia, and/or intravenous antibiotics. Seventy percent of patients with a grade 3 or 4 mucositis will require a feeding tube. Mucositis also has the potential to impact the effectiveness of cancer treatment as it is a dose-limiting toxicity and results in cessation or reduction of treatment in 35% of patients (2,3,4)

Current standard of care focuses on palliation and includes systemic opiate analgesics for moderate to severe mucositis pain, topical anesthetics and mucosal coating agents such as lidocaine,
Sponsor: Aaron Cumpston, PharmD

Current Primary Outcome: Reduction in pain scores [ Time Frame: 1 hour, 1 day, 2 days and 3 days after start of ketamine mouthwashes ]

Reduction in pain score as reported after use of ketamine mouthwash on a numeric scale compared to a baseline assessment.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]
    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 ]
    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 ]
    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 ]
    Daily narcotic analgesic use will be recorded.
  • Reduction in topical lidocaine usage [ Time Frame: Days 1, 2 and 3 after start of ketamine mouthwashes ]
    Daily topical lidocaine usage will be recorded.
  • Quality of life [ Time Frame: Days 1, 2 and 3 after start of ketamine mouthwashes ]
    Sleep quality, as reported by the subject on a numeric scale, and food intake will be used as surrogate markers of quality of life.


Original Secondary Outcome: Same as current

Information By: West Virginia University

Dates:
Date Received: March 27, 2012
Date Started: February 2012
Date Completion:
Last Updated: December 11, 2015
Last Verified: December 2015