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

This study is currently recruiting participants.
Verified May 2013 by Dartmouth-Hitchcock Medical Center
Sponsor:
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT01653327
First received: July 24, 2012
Last updated: May 7, 2013
Last verified: May 2013
History of Changes
  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 Intervention Phase
Mucositis
Head and Neck Cancer
 Drug: Ketamine
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Analgesic Effects of Topical Ketamine Mouthwash in Patients Receiving Chemoradiation or Radiotherapy for Head and Neck Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Dartmouth-Hitchcock Medical Center:

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.


Estimated Enrollment: 10
Study Start Date: June 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ketamine
Twenty milligrams of ketamine will be dissolved in 4 mL of pharmaceutical cherry syrup and 1 ml of normal saline.
 Drug: 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.
 Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01653327

Contacts
Contact: Thomas H Davis, MD 603-650-8626 thomas.h.davis@hitchcock.org

Locations
United States, New Hampshire
Dartmouth-Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Research Nurse     800-639-6918     cancer.research.nurse@dartmouth.edu    
Principal Investigator: Thomas H Davis, MD            
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Investigators
Principal Investigator: Thomas H David, MD Dartmouth-Hitchcock Medical Center
  More Information

No publications provided

Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT01653327     History of Changes
Other Study ID Numbers: D1022
Study First Received: July 24, 2012
Last Updated: May 7, 2013
Health Authority: United States: Data Safety Monitoring and Accrual Committee
United States: Federal Government
United States: Food and Drug Administration
United States: Committee for the Protection of Human Subjects

Keywords provided by Dartmouth-Hitchcock Medical Center:
mucositis
head and neck
cancer
radiation therapy
 chemoradiation
oral
pain

Additional relevant MeSH terms:
Head and Neck Neoplasms
Mucositis
Neoplasms by Site
Neoplasms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases
Analgesics
Ketamine
Sensory System Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013