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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

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.

Condition or disease Intervention/treatment Phase
Mucositis Head and Neck Cancer Drug: Ketamine Drug: Placebo Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : June 2010
Actual Primary Completion Date : August 16, 2016
Actual Study Completion Date : August 16, 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01653327


Locations
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United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Investigators
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Principal Investigator: Thomas H David, MD Dartmouth-Hitchcock Medical Center

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Responsible Party: Thomas Davis, Staff Physician, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT01653327     History of Changes
Other Study ID Numbers: D1022
First Posted: July 31, 2012    Key Record Dates
Results First Posted: September 28, 2018
Last Update Posted: September 28, 2018
Last Verified: September 2018

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

Additional relevant MeSH terms:
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Head and Neck Neoplasms
Mucositis
Neoplasms by Site
Neoplasms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
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