Using gabapentin and ketamine to manage pain in head and neck cancer patients
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
This study is testing a combination of gabapentin and ketamine to see if it can safely help manage pain for patients with advanced head and neck cancer who are receiving treatment.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Vanderbilt-Ingram Cancer Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Nashville, Tennessee) |
| Trial ID | NCT05156060 on ClinicalTrials.gov |
What this trial studies
This study aims to determine a safe and effective dose of gabapentin and ketamine for patients with locally advanced head and neck cancer undergoing chemoradiation. The primary objective is to establish the maximum tolerated dose of ketamine when combined with gabapentin, with a maximum planned dose of 40 mg three times a day. Additionally, the study will evaluate the feasibility and tolerability of this combination therapy, while also exploring its effects on pain, symptom burden, functionality, and quality of life for the participants.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21 and older with histologically proven locally advanced non-metastatic head and neck cancer who are scheduled for chemoradiation therapy.
Not a fit: Patients currently taking gabapentin or ketamine, or those with a history of non-tolerance to these medications, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve pain management and quality of life for patients undergoing treatment for head and neck cancer.
How similar studies have performed: While the combination of gabapentin and ketamine has been explored in other contexts, this specific approach for head and neck cancer pain management is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Nashville, Tennessee
- Vanderbilt-Ingram Cancer Center — Nashville, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: Natalie Lockney, MD — Vanderbilt-Ingram Cancer Center
- Study coordinator: Vanderbilt-Ingram Service for Timely Access
- Email: cip@vumc.org
- Phone: 800-811-8480
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.