Actively Recruiting
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 Chemoradiation
Led by Natalie Lockney · Updated on 2024-10-21
64
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to find a safe and feasible dose for using a combination of gabapentin and ketamine to prevent and treat acute and chronic pain in patients with locally advanced head and neck cancer undergoing chemoradiation. The study focuses on determining the highest dose of ketamine that can be tolerated when combined with gabapentin, while also assessing the treatment's feasibility and tolerability. Additionally, it explores effects on pain, symptom burden, functionality, and quality of life. Participants will take gabapentin by mouth and ketamine administered intranasally, both three times daily. The ketamine dose will be increased up to a planned maximum of 40 mg taken three times a day. This trial includes both Phase I and Phase II periods; Phase I lasts about 28 days to establish the maximum tolerated ketamine dose, followed by Phase II which monitors adverse events up to 30 days after treatment. During the study, participants will be closely monitored for side effects and tolerability using standard criteria. Researchers will assess pain levels, symptoms, daily functioning, and overall quality of life throughout the treatment. The study involves regular evaluations to measure safety and treatment effects, with participation lasting through the treatment and follow-up periods as defined by each phase.
CONDITIONS
Brief Title
Gabapentin & Ketamine for Prevention/Treatment of Acute/Chronic Pain in Locally Advanced Head and Neck Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed 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 performance status 0-2
- Age 21 years or older
- English speaking
You will not qualify if you...
- Currently taking gabapentin or ketamine
- Previous intolerance to gabapentin or ketamine
- Unable to use intranasal ketamine due to anatomical reasons
- History of seizure disorder
- History of schizophrenia
- History of increased intracranial pressure
- Glomerular filtration rate less than 30 mL/min/1.73 m2
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 28 days
Participants take gabapentin by mouth and ketamine intranasally three times a day to prevent and treat acute and chronic pain during chemoradiation therapy for head and neck cancer.
Weekly visits for up to 4 weeks
Duration - Up to 30 days post-treatment
Participants are monitored for adverse events and symptom changes after treatment ends.
1 to 2 visits depending on participant condition
Trial Site Locations
Total: 1 location
1
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
Research Team
V
Vanderbilt-Ingram Service for Timely Access
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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