Gabapentin & Ketamine for Prevention/Treatment of Acute/Chronic Pain in Locally Advanced Head and Neck Cancer
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 Primary or Adjuvant Chemoradiation
1 other identifier
interventional
64
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 head-and-neck-cancer
Started Jan 2022
Typical duration for phase_1 head-and-neck-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 30, 2021
CompletedFirst Posted
Study publicly available on registry
December 14, 2021
CompletedStudy Start
First participant enrolled
January 24, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
ExpectedOctober 21, 2024
October 1, 2024
3.9 years
November 30, 2021
October 17, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
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
Approximately 28 days (Phase I)
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
Up to 30 post-treatment (Phase II)
Study Arms (1)
Gabapentin plus Ketamine
EXPERIMENTALGabapentin and Ketamine will be taken 3 times per day.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Natalie Lockneylead
Study Sites (1)
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Natalie Lockney, MD
Vanderbilt-Ingram Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Sponsor Investigator
Study Record Dates
First Submitted
November 30, 2021
First Posted
December 14, 2021
Study Start
January 24, 2022
Primary Completion
December 31, 2025
Study Completion (Estimated)
December 31, 2026
Last Updated
October 21, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share