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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 30 post-treatment (phase ii)

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 30 post-treatment (phase ii)

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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)

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

~1090

0 / 5Eligibility criteria met

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacant positions in this experiment for participants?

"That is correct. The trial, which is currently seeking 44 patients from 1 location, was originally posted on clinicaltrials.gov on January 24th, 2022 and was edited February 16th, 2022."

Answered by AI

Why is Ketamine used as a medical treatment?

"While anesthesiologists most commonly use ketamine, it can also help treat conditions like neuralgia, epilepsies, and pain management during surgery."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Natalie Lockney 2022. "Gabapentin & Ketamine for Prevention/Treatment of Acute/Chronic Pain in Locally Advanced Head and Neck Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05156060.

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