Recruiting at 1 site Phase 1, Phase 2 Head and Neck Cancer

Head and Neck Cancer study: Gabapentin vs Ketamine

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

ClinicalTrials.gov ID: NCT05156060

What this study is testing

What is Gabapentin?

Gabapentin is an investigational medicine, taken by mouth, being studied as a potential treatment for head and neck cancer.

Also referred to as Neurontin.

Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
The study aims to find a safe and feasible dose of gabapentin and ketamine for use before and during cancer treatment.
Who it's for
Patients with locally advanced head and neck cancer who are receiving chemoradiation.
What's involved
Participants will receive gabapentin and ketamine as part of their treatment and will attend scheduled visits and tests to monitor safety and pain levels.
  • Phase 2: a mid-size study of how well it works

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 21 and older

You may be able to join 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

You likely can't join 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
See the full eligibility criteria
Who can join
  • 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
What rules you out
  • 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

The study team makes the final eligibility decision.

Where it is enrolling

  • Nashville, Tennessee, United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 21 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

This study is enrolling now at Nashville, Tennessee, United States. Enter your location above to see the nearest enrolling site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.