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Gabapentin + Ketamine for Head and Neck Cancer Pain Management

Phase 1 & 2
Recruiting
Led By Natalie Lockney, MD
Research Sponsored by Dianne Lou
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 21 years
Histologically proven cancer of the head and neck cancer
Must not have
Currently on gabapentin or ketamine
History of increased intracranial pressure
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 post-treatment (phase ii)
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a combination of gabapentin and ketamine to see if it is safe and effective to use as a prophylactic measure in head and neck cancer patients undergoing chemoradiation.

Who is the study for?
This trial is for adults over 21 with advanced but non-metastatic head and neck cancer, who are about to undergo or are currently receiving radiation or chemoradiation. Participants must be able to consent and speak English. Those already on gabapentin or ketamine, with a history of seizures, schizophrenia, high brain pressure, or poor kidney function cannot join.
What is being tested?
The study is testing the safety and appropriate dose of gabapentin combined with ketamine given before treatment to prevent acute and chronic pain in patients undergoing chemoradiation for head and neck cancer.
What are the potential side effects?
Gabapentin may cause dizziness, fatigue, and swelling in extremities. Ketamine can lead to changes in blood pressure, disorientation, mood swings, nausea, and potentially hallucinations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 21 years old or older.
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My cancer is in the head or neck area, confirmed by a biopsy.
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My cancer is advanced but hasn't spread to distant parts of my body.
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I am scheduled for initial or additional radiation or combined chemotherapy and radiation treatment.
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I can take care of myself and perform daily activities.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently taking gabapentin or ketamine.
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I have had issues with high pressure inside my skull.
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I have had bad reactions to gabapentin or ketamine.
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My kidney function is severely reduced.
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I have a history of seizures.
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I cannot use nasal sprays due to my nose's structure.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 post-treatment (phase ii)
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 post-treatment (phase ii) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Count of participants with adverse events (Common Terminology Criteria for Adverse Events Criteria 4.0)
Establish the maximum tolerated dose of ketamine in combination with gabapentin (per Common Terminology Criteria for Adverse Events Criteria 4.0)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Gabapentin plus KetamineExperimental Treatment2 Interventions
Gabapentin and Ketamine will be taken 3 times per day.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gabapentin
2013
Completed Phase 4
~1550
Ketamine
2011
Completed Phase 4
~1120

Find a Location

Who is running the clinical trial?

Dianne LouLead Sponsor
Natalie LockneyLead Sponsor
Natalie Lockney, MDPrincipal InvestigatorVanderbilt-Ingram Cancer Center

Media Library

Gabapentin (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05156060 — Phase 1 & 2
Head and Neck Cancers Research Study Groups: Gabapentin plus Ketamine
Head and Neck Cancers Clinical Trial 2023: Gabapentin Highlights & Side Effects. Trial Name: NCT05156060 — Phase 1 & 2
Gabapentin (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05156060 — Phase 1 & 2
~18 spots leftby Dec 2025
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