Gabapentin & Ketamine for Prevention/Treatment of Acute/Chronic Pain in Locally Advanced Head and Neck Cancer

• Status: Not yet recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dianne Lou
• Treatments: Gabapentin; Ketamine

Criteria

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