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

• Status: Completed
• Trial end date: 2016-08-16
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dartmouth-Hitchcock Medical Center
• Treatments: Analgesics; Ketamine

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