RecruitingPhase 1Phase 2NCT05156060

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


Sponsor

Natalie Lockney

Enrollment

64 participants

Start Date

Jan 24, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether combining gabapentin (a nerve pain medication) and ketamine (an anesthetic used in low doses for pain) can prevent or reduce severe pain in patients with locally advanced head and neck cancer undergoing radiation or chemoradiation therapy. Pain from this treatment can be severe and long-lasting. **You may be eligible if...** - You are 21 or older and have confirmed head and neck cancer - Your cancer is locally advanced but has not spread to distant organs - You are planned to receive radiation therapy or chemoradiation as your primary or follow-up treatment - You are in reasonably good health (ECOG performance status 0–2) - You speak English **You may NOT be eligible if...** - You are already taking gabapentin or ketamine - You have previously had a bad reaction to gabapentin or ketamine - Your anatomy prevents you from receiving ketamine through the nose - You have a history of seizures, schizophrenia, or increased pressure in the brain - Your kidney function is significantly impaired (GFR below 30) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGabapentin

Taken by mouth 3 times per day

DRUGKetamine

Administered intranasally 3 times per day


Locations(1)

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

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NCT05156060


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