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

RECRUITINGPhase 1/2Sponsored by Natalie Lockney
Actively Recruiting
PhasePhase 1/2
SponsorNatalie Lockney
Started2022-01-24
Est. completion2025-12-31
Eligibility
Age21 Years+
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →

NCT05156060

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.

Eligibility

Age: 21 Years+Healthy volunteers accepted
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

Conditions3

CancerHead and Neck CancerLocally Advanced Head and Neck Carcinoma

Locations1 site

Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232
Vanderbilt-Ingram Service for Timely Access800-811-8480cip@vumc.org

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