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Analgesic Effects of Topical Ketamine Mouthwash in Patients Receiving Chemoradiation or Radiotherapy for Head & Neck Cancer

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ClinicalTrials.gov Identifier: NCT01653327
Recruitment Status : Completed
First Posted : July 31, 2012
Results First Posted : September 28, 2018
Last Update Posted : September 28, 2018
Sponsor:
Information provided by (Responsible Party):
Thomas Davis, Dartmouth-Hitchcock Medical Center

Tracking Information
First Submitted Date  ICMJE July 24, 2012
First Posted Date  ICMJE July 31, 2012
Results First Submitted Date  ICMJE July 3, 2018
Results First Posted Date  ICMJE September 28, 2018
Last Update Posted Date September 28, 2018
Study Start Date  ICMJE June 2010
Actual Primary Completion Date August 16, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 26, 2018)
Change in Pain Score [ Time Frame: After 9-10 doses, expected average 1 month ]
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 determine average pain scores. Pain will be measured using a 0-10 scale with 0 representing no pain; 1-3 representing mild pain; 4-6 representing moderate pain; and 7-10 representing severe pain. The effect of ketamine in comparison to placebo will be estimated with a mean and confidence interval. Proportional changes 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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 30, 2012)
Reduction in Pain Score [ Time Frame: After 9 doses, expected average 1 month ]
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 26, 2018)
Duration of Analgesic Effect [ Time Frame: After 9-10 doses, expected average 1 month ]
The secondary analysis is testing and estimating the analgesic effect of ketamine in comparison to placebo. Pain assessment will be analyzed using descriptive statistics. We will also determine average duration of analgesia. The effect of ketamine in comparison to placebo will be estimated with a mean and confidence interval.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Analgesic Effects of Topical Ketamine Mouthwash in Patients Receiving Chemoradiation or Radiotherapy for Head & Neck Cancer
Official Title  ICMJE 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

We would like to determine the effectiveness of ketamine mouthwash in providing pain relief to subjects with head and neck cancer suffering from mucositis, a common adverse event of radiation therapy and chemoradiation therapy. Ketamine is a schedule III controlled substance that is generally used to provide anesthesia for short diagnostic and surgical procedures.

Ten subjects will be randomized to two treatment arms. Group A will receive ketamine on Monday, placebo on Wednesday, and ketamine on Friday. Group B will receive placebo on Monday, ketamine on Wednesday, and placebo on Friday. Each subject will swish the study drug or placebo for 2 minutes and spit it out. The use of non-maintenance mucositis medications such as DLM solution will not be allowed during the clinic visit. Subjects may resume non-maintenance mucositis medications at home.

Subjects will be asked to document adverse effects and pain scores at 30, 45, and 60 minutes after study medication. The Richmond Agitation and Sedation Scale (RASS) will be used to determine a subject's sedation level, if necessary. Treatment will last for up to 6 weeks unless an illness or an event occurs that prevents continuation, intolerance to the agent, adverse events, resolution of mucositis pain, or the decision to withdraw from the study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Mucositis
  • Head and Neck Cancer
Intervention  ICMJE
  • 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 Arms  ICMJE
  • Active Comparator: Ketamine
    Twenty milligrams of ketamine will be dissolved in 4 mL of pharmaceutical cherry syrup and 1 ml of normal saline.
    Intervention: Drug: Ketamine
  • Placebo Comparator: Placebo
    The placebo will consist of 4 ml of cherry syrup and 1 ml of normal saline.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 26, 2018)
11
Original Estimated Enrollment  ICMJE
 (submitted: July 30, 2012)
10
Actual Study Completion Date  ICMJE August 16, 2016
Actual Primary Completion Date August 16, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01653327
Other Study ID Numbers  ICMJE D1022
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Thomas Davis, Dartmouth-Hitchcock Medical Center
Original Responsible Party Dartmouth-Hitchcock Medical Center
Current Study Sponsor  ICMJE Dartmouth-Hitchcock Medical Center
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Thomas H David, MD Dartmouth-Hitchcock Medical Center
PRS Account Dartmouth-Hitchcock Medical Center
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP