Gabapentin & Ketamine for Prevention/Treatment of Acute/Chronic Pain in Locally Advanced Head and Neck Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age21+
SponsorNatalie Lockney
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Gabapentin
DrugTaken by mouth 3 times per day
Ketamine
DrugAdministered intranasally 3 times per day
Treatment groups
64 Participants
are divided into 1 treatment groupGroup A: Gabapentin plus KetamineExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Establish the maximum tolerated dose of ketamine in combination with gabapentin (per Common Terminology Criteria for Adverse Events Criteria 4.0)
Up to a maximum planned dose of 40 mg three times a day
Time frame
Approximately 28 days (Phase I)2
Count of participants with adverse events (Common Terminology Criteria for Adverse Events Criteria 4.0)
Number of Participants With Grade 3 or 4 Adverse Events
Time frame
Up to 30 post-treatment (Phase II)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Natalie Lockney
Lead sponsor
Vanderbilt-Ingram Cancer Center
Sponsor institution
Source ClinicalTrials.gov