Head and Neck Cancer, Locally Advanced Head and Neck Carcinoma
Conditions
Brief 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.
Detailed description
Objectives: * To establish the maximum tolerated dose of ketamine in combination with gabapentin up to a maximum planned dose of 40 mg three times a day. * To evaluate feasibility and tolerability Exploratory: \- To assess pain, symptom burden, functionality, and quality of life
Interventions
DRUGGabapentin
Taken by mouth 3 times per day
DRUGKetamine
Administered intranasally 3 times per day
Sponsors
Natalie Lockney
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Establish the maximum tolerated dose of ketamine in combination with gabapentin (per Common Terminology Criteria for Adverse Events Criteria 4.0) | Approximately 28 days (Phase I) | Up to a maximum planned dose of 40 mg three times a day |
| Count of participants with adverse events (Common Terminology Criteria for Adverse Events Criteria 4.0) | Up to 30 post-treatment (Phase II) | Number of Participants With Grade 3 or 4 Adverse Events |
Countries
United States
Contacts
Primary ContactVanderbilt-Ingram Service for Timely Access
Outcome results
None listed