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

Disease Sites:

Head/Neck, Phase I

Staging:

Phase I/II

Age Group:

Adults

Therapies:

Not Available

Drugs:

Not Available

Principal Investigator(s):

Lockney, Natalie

Scope:

Local

Participating Institutions:

Vanderbilt University

Open Date:

01-11-2022

Trial Type:

Treatment

Protocol ID:

VICCHNP2173

National Clinical Trial ID:

NCT05156060

Eligibility

Ages Eligible for Study:

Not Available

Genders Eligible for Study:

Not Available

Accepts Healthy Volunteers?:

Not Available

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

Clinical Trials Search at Vanderbilt-Ingram Cancer Center

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

Eligibility