Gabapentin & Ketamine for Prevention/Treatment of Acute/Chronic Pain in Locally Advanced Head and Neck Cancer
NCT ID: NCT05156060
Last Updated: 2024-10-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
64 participants
INTERVENTIONAL
2022-01-24
2026-12-31
Brief Summary
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Detailed Description
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* 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
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Gabapentin plus Ketamine
Gabapentin and Ketamine will be taken 3 times per day.
Gabapentin
Taken by mouth 3 times per day
Ketamine
Administered intranasally 3 times per day
Interventions
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Gabapentin
Taken by mouth 3 times per day
Ketamine
Administered intranasally 3 times per day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
21 Years
ALL
No
Sponsors
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Natalie Lockney
OTHER
Responsible Party
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Natalie Lockney
Sponsor Investigator
Principal Investigators
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Natalie Lockney, MD
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt-Ingram Cancer Center
Locations
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Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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VICC HNP 2173
Identifier Type: -
Identifier Source: org_study_id
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