Gabapentin & Ketamine for Prevention/Treatment of Acute/Chronic Pain in Locally Advanced Head and Neck Cancer
Recruiting now · Phase 1/Phase 2
Conditions studied: Head and Neck Cancer, Locally Advanced Head and Neck Carcinoma
In brief
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.
Key facts
- Study ID
- NCT05156060
- Run by
- Natalie Lockney
- People needed
- 64
- Starts
- 2022-01-24
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2024-10-21
Who can join
Age: 21 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Vanderbilt-Ingram Cancer Center — Nashville, Tennessee, United States (enrolling)
Full record on ClinicalTrials.gov
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