Gabapentin & Ketamine for Prevention/Treatment of Acute/Chronic Pain in Locally Advanced Head and Neck Cancer

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Natalie Lockney
Study ID
NCT05156060
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Gabapentin — DRUG
    Taken by mouth 3 times per day
  • Ketamine — DRUG
    Administered intranasally 3 times per day

Study Details

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.

Key Dates

Start date
Jan 24, 2022
Status verified
Oct 2024
Primary completion
Dec 31, 2025
Completion
Dec 31, 2026

Study Design

Enrollment
64 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Gabapentin plus Ketamine
    Gabapentin and Ketamine will be taken 3 times per day.

Primary Outcome Measure

Establish the maximum tolerated dose of ketamine in combination with gabapentin (per Common Terminology Criteria for Adverse Events Criteria 4.0) [ Time Frame: Approximately 28 days (Phase I) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Vanderbilt-Ingram Cancer CenterNashvilleTennessee37232
Vanderbilt-Ingram Service for Timely Access
[email protected]
800-811-8480
Natalie Lockney, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Nashville, TN

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
Vanderbilt-Ingram Cancer Center· Nashville, TN

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