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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Mucositis, Head and Neck Cancer

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Trial Information

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


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

Type of Study:

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

Outcome Measure:

Reduction in Pain Score

Outcome Description:

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.

Outcome Time Frame:

After 9 doses, expected average 1 month

Safety Issue:

No

Principal Investigator

Thomas H David, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dartmouth-Hitchcock Medical Center

Authority:

United States: Data Safety Monitoring and Accrual Committee

Study ID:

D1022

NCT ID:

NCT01653327

Start Date:

June 2010

Completion Date:

December 2014

Related Keywords:

  • Mucositis
  • Head and Neck Cancer
  • mucositis
  • head and neck
  • cancer
  • radiation therapy
  • chemoradiation
  • oral
  • pain
  • Head and Neck Neoplasms
  • Mucositis

Name

Location

Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756