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.
ConditionMucositis
Head and Neck Cancer
InterventionDrug: Ketamine
Drug: Placebo
PhasePhase 2
SponsorDartmouth-Hitchcock Medical Center
Responsible PartyDartmouth-Hitchcock Medical Center
ClinicalTrials.gov IdentifierNCT01653327
First ReceivedJuly 24, 2012
Last UpdatedFebruary 14, 2014
Last verifiedFebruary 2014

Tracking Information[ + expand ][ + ]

First Received DateJuly 24, 2012
Last Updated DateFebruary 14, 2014
Start DateJune 2010
Estimated Primary Completion DateDecember 2014
Current Primary Outcome MeasuresReduction 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 MeasuresNot Provided

Descriptive Information[ + expand ][ + ]

Brief TitleAnalgesic Effects of Topical Ketamine Mouthwash in Patients Receiving Chemoradiation or Radiotherapy for Head and Neck Cancer
Official TitleAnalgesic 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 DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 2
Study DesignAllocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
Condition
  • Mucositis
  • Head and Neck Cancer
InterventionDrug: 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)
  • Active Comparator: Ketamine
    Twenty milligrams of ketamine will be dissolved in 4 mL of pharmaceutical cherry syrup and 1 ml of normal saline.
  • Placebo Comparator: Placebo
    The placebo will consist of 4 ml of cherry syrup and 1 ml of normal saline.

Recruitment Information[ + expand ][ + ]

Recruitment StatusRecruiting
Estimated Enrollment10
Estimated Completion DateDecember 2014
Estimated Primary Completion DateJune 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
GenderBoth
Ages18 Years
Accepts Healthy VolunteersNo
ContactsContact: Thomas H Davis, MD
603-650-8626
thomas.h.davis@hitchcock.org
Location CountriesUnited States

Administrative Information[ + expand ][ + ]

NCT Number NCT01653327
Other Study ID NumbersD1022
Has Data Monitoring CommitteeYes
Information Provided ByDartmouth-Hitchcock Medical Center
Study SponsorDartmouth-Hitchcock Medical Center
CollaboratorsNot Provided
Investigators Principal Investigator: Thomas H David, MD Dartmouth-Hitchcock Medical Center
Verification DateFebruary 2014

Locations[ + expand ][ + ]

Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Contact: Research Nurse | 800-639-6918 | cancer.research.nurse@dartmouth.edu
Principal Investigator: Thomas H Davis, MD
Recruiting