RecruitingPhase 1ketamine

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

Sponsored by Natalie Lockney

NCT ID
NCT05156060
Target Enrollment
64 participants
Start Date
2022-01-24
Est. Completion
2026-12-31

About This Study

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 Studied

Head and Neck CancerLocally Advanced Head and Neck Carcinoma

Interventions

  • •Gabapentin
  • •Ketamine

Eligibility

Age:21 Years - N/A
Healthy Volunteers:No
View full eligibility 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

Study Locations (1)

Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States

Interested in this trial?

Contact the study team to learn more about eligibility and enrollment.

Vanderbilt-Ingram Service for Timely Access
CONTACT
800-811-8480cip@vumc.org
View on ClinicalTrials.gov
Data Source
ClinicalTrials.gov

Last updated from source

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