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

Completed · Phase 2 · Has a placebo group

Conditions studied: Mucositis, Head and Neck Cancer

In brief

* 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.

Key facts

Study ID

NCT01653327

Run by

Dartmouth-Hitchcock Medical Center

People needed

11

Starts

2010-06-01

Expected to finish

2016-08-16

Last updated by the study team

2018-09-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States

Full record on ClinicalTrials.gov

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