Analgesic Effects of Topical Ketamine Mouthwash in Patients Receiving Chemoradiation or Radiotherapy for Head and Neck Cancer
Overview[ - collapse ][ - ]
Purpose | - The primary objective is to determine the reduction in pain score by ketamine mouthwash compared to placebo in head and neck cancer patients with refractory mucositis. - The secondary objectives are to describe the duration of analgesia and adverse effects associated with ketamine and placebo. |
---|---|
Condition | Mucositis Head and Neck Cancer |
Intervention | Drug: Ketamine Drug: Placebo |
Phase | Phase 2 |
Sponsor | Dartmouth-Hitchcock Medical Center |
Responsible Party | Dartmouth-Hitchcock Medical Center |
ClinicalTrials.gov Identifier | NCT01653327 |
First Received | July 24, 2012 |
Last Updated | February 14, 2014 |
Last verified | February 2014 |
Tracking Information[ + expand ][ + ]
First Received Date | July 24, 2012 |
---|---|
Last Updated Date | February 14, 2014 |
Start Date | June 2010 |
Estimated Primary Completion Date | December 2014 |
Current Primary Outcome Measures | Reduction in Pain Score [Time Frame: After 9 doses, expected average 1 month] [Designated as safety issue: No]The primary analysis is testing and estimating the effect of ketamine in comparison to placebo. Pain assessment will be analyzed using descriptive statistics. We will also determine average pain scores and average duration of analgesia. The effect of ketamine in comparison to placebo will be estimated with a mean and confidence interval. Proportional reductions in pain scores (post-treatment pain score ÷ pre-treatment pain score) will be calculated and similarly analyzed. The proportion of subjects experiencing a reduction in pain scores of >33% will be calculated. |
Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
Brief Title | Analgesic Effects of Topical Ketamine Mouthwash in Patients Receiving Chemoradiation or Radiotherapy for Head and Neck Cancer |
---|---|
Official Title | Analgesic Effects of Topical Ketamine Mouthwash in Patients Receiving Chemoradiation or Radiotherapy for Head and Neck Cancer |
Brief Summary | - The primary objective is to determine the reduction in pain score by ketamine mouthwash compared to placebo in head and neck cancer patients with refractory mucositis. - The secondary objectives are to describe the duration of analgesia and adverse effects associated with ketamine and placebo. |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 2 |
Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care |
Condition |
|
Intervention | Drug: Ketamine Twenty milligrams of ketamine will be dissolved in 4 mL of pharmaceutical cherry syrup and 1 ml of normal saline. Drug: Placebo |
Study Arm (s) |
|
Recruitment Information[ + expand ][ + ]
Recruitment Status | Recruiting |
---|---|
Estimated Enrollment | 10 |
Estimated Completion Date | December 2014 |
Estimated Primary Completion Date | June 2014 |
Eligibility Criteria | Inclusion Criteria: - Subjects diagnosed with head and neck tumors (any histology) receiving ongoing chemoradiation or radiation therapy - Subjects with mucositis pain refractory to topical management, defined as any self-reported pain score of > 2 in the 24 hours prior to enrollment despite use of topical agents as prescribed - Age ≥ 18 years - Ability to understand and willingness to consent and to sign consent form Exclusion Criteria: - Active substance abuse at time of registration (alcohol, drugs, non-prescription use of controlled substances) - Subjects with history of allergic reactions to ketamine - Persistent oral bleeding: > 15 mL (estimated) per day - Pregnancy or breast feeding |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Contact: Thomas H Davis, MD 603-650-8626 thomas.h.davis@hitchcock.org |
Location Countries | United States |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01653327 |
---|---|
Other Study ID Numbers | D1022 |
Has Data Monitoring Committee | Yes |
Information Provided By | Dartmouth-Hitchcock Medical Center |
Study Sponsor | Dartmouth-Hitchcock Medical Center |
Collaborators | Not Provided |
Investigators | Principal Investigator: Thomas H David, MD Dartmouth-Hitchcock Medical Center |
Verification Date | February 2014 |
Locations[ + expand ][ + ]
Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire, United States, 03756 Contact: Research Nurse | 800-639-6918 | cancer.research.nurse@dartmouth.eduPrincipal Investigator: Thomas H Davis, MD Recruiting |
---|