Clinical trial · Interventional
Gabapentin & Ketamine for Prevention/Treatment of Acute/Chronic Pain in Locally Advanced Head and Neck Cancer
Phase I/II Trial of Gabapentin Plus Ketamine for Prevention and Treatment of Acute and Chronic Pain in Locally Advanced Head and Neck Cancer Patients Undergoing Primary or Adjuvant Chemoradiation
NCT05156060CI-TRIAL-00081771recruitingPhase 1 / Phase 2ClinicalTrials.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)
This is a study to establish a safe and feasible dose for prophylactic use of a combination of gabapentin and ketamine in head and neck cancer patients undergoing chemoradiation.
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 |
| Locally Advanced Head and Neck Carcinoma | Head and Neck Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gabapentin | Drug | — | UNRESOLVED |
| Ketamine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Gabapentin plus Ketamine
- description
- Gabapentin and Ketamine will be taken 3 times per day.
- interventionNames
- Drug: Gabapentin
- Drug: Ketamine
Primary outcomes (2)
- measure
- Establish the maximum tolerated dose of ketamine in combination with gabapentin (per Common Terminology Criteria for Adverse Events Criteria 4.0)
- timeFrame
- Approximately 28 days (Phase I)
- description
- Up to a maximum planned dose of 40 mg three times a day
- measure
- Count of participants with adverse events (Common Terminology Criteria for Adverse Events Criteria 4.0)
- timeFrame
- Up to 30 post-treatment (Phase II)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven cancer of the head and neck cancer * Locally advanced non-metastatic disease (T3N0M0, T4N0M0, T1-4N1-3M0) * Planned primary or adjuvant radiation or chemoradiation therapy * Willing and able to provide informed consent * ECOG PS 0-2 * Age ≥ 21 years * English speaking Exclusion Criteria: * Currently on gabapentin or ketamine * Prior non-tolerance of gabapentin or ketamine * Unable to administer ketamine intranasally due to anatomical restrictions * History of seizure disorder * History of schizophrenia * History of increased intracranial pressure * Glomerular filtration rate \<30 mL/min/1.73 m2
References
Publications (0)
Data not yet available
No reference posted for this study.