NCT05156060 Gabapentin & Ketamine for Prevention/Treatment of Acute/Chronic Pain in Locally Advanced Head and Neck Cancer
| NCT ID | NCT05156060 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Natalie Lockney |
| Condition | Head and Neck Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 64 participants |
| Start Date | 2022-01-24 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 64 participants in total. It began in 2022-01-24 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion 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 Exclusion Criteria: * 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
Contact & Investigator
Natalie Lockney, MD
PRINCIPAL INVESTIGATOR
Vanderbilt-Ingram Cancer Center
Frequently Asked Questions
Who can join the NCT05156060 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, studying Head and Neck Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05156060 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05156060 currently recruiting?
Yes, NCT05156060 is actively recruiting participants. Contact the research team at cip@vumc.org for enrollment information.
Where is the NCT05156060 trial being conducted?
This trial is being conducted at Nashville, United States.
Who is sponsoring the NCT05156060 clinical trial?
NCT05156060 is sponsored by Natalie Lockney. The principal investigator is Natalie Lockney, MD at Vanderbilt-Ingram Cancer Center. The trial plans to enroll 64 participants.
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