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

Phase 1

Recruiting

• Conditions: Head and Neck Cancer; Locally Advanced Head and Neck Carcinoma
• Interventions: Drug: Gabapentin; Drug: Ketamine

• Registration Number: NCT05156060
• Lead Sponsor: Natalie Lockney

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.

Detailed Description

Objectives:

* To establish the maximum tolerated dose of ketamine in combination with gabapentin up to a maximum planned dose of 40 mg three times a day.

* To evaluate feasibility and tolerability

Exploratory:

- To assess pain, symptom burden, functionality, and quality of life

Study Timeline

• Study First Submitted: 2021-11-30
• Study First Submitted QC: 2021-11-30
• Study First Posted: 2021-12-14
• Study Start: 2022-01-24
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-17
• Last Update Posted: 2024-10-21
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Gabapentin plus Ketamine	Gabapentin	Gabapentin and Ketamine will be taken 3 times per day.
Gabapentin plus Ketamine	Ketamine	Gabapentin and Ketamine will be taken 3 times per day.

Primary Outcome Measures

Name	Time	Method
Establish the maximum tolerated dose of ketamine in combination with gabapentin (per Common Terminology Criteria for Adverse Events Criteria 4.0)	Approximately 28 days (Phase I)	Up to a maximum planned dose of 40 mg three times a day
Count of participants with adverse events (Common Terminology Criteria for Adverse Events Criteria 4.0)	Up to 30 post-treatment (Phase II)	Number of Participants With Grade 3 or 4 Adverse Events

Trial Locations

Locations (1)

Vanderbilt-Ingram Cancer Center; 🇺🇸 Nashville, Tennessee, United States