Gabapentin & Ketamine for Prevention/Treatment of Acute/Chronic Pain in Locally Advanced Head and Neck Cancer
Purpose
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
- Head and Neck Cancer
- Locally Advanced Head and Neck Carcinoma
Eligibility
- Eligible Ages
- Over 21 Years
- Eligible Genders
- All
- Accepts 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
Study Design
- Phase
- Phase 1/Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Gabapentin plus Ketamine |
Gabapentin and Ketamine will be taken 3 times per day. |
|
Recruiting Locations
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee 37232
Nashville, Tennessee 37232
More Details
- Status
- Recruiting
- Sponsor
- Natalie Lockney
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