Clinical trial · Interventional
Analgesic Effects of Topical Ketamine Mouthwash in Patients Receiving Chemoradiation or Radiotherapy for Head & Neck Cancer
Analgesic Effects of Topical Ketamine Mouthwash in Patients Receiving Chemoradiation or Radiotherapy for Head and Neck Cancer
NCT01653327CI-TRIAL-00035079completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
* 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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Mucositis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ketamine | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Ketamine
- description
- Twenty milligrams of ketamine will be dissolved in 4 mL of pharmaceutical cherry syrup and 1 ml of normal saline.
- interventionNames
- Drug: Ketamine
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- The placebo will consist of 4 ml of cherry syrup and 1 ml of normal saline.
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Change in Pain Score
- timeFrame
- After 9-10 doses, expected average 1 month
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.