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Prevention study for Head and Neck Cancer
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, given as a pill 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
- 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.
- 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
- 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
- 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's taking place
- 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 - 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?
Study sites include Nashville, Tennessee, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.