NCT05156060

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: Natalie Lockney · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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

Conditions

• Head and Neck Cancer
• Locally Advanced Head and Neck Carcinoma

Interventions

Type	Name	Description
DRUG	Gabapentin	Taken by mouth 3 times per day
DRUG	Ketamine	Administered intranasally 3 times per day

Timeline

• Start date: 2022-01-24
• Primary completion: 2025-12-31
• Completion: 2026-12-31
• First posted: 2021-12-14
• Last updated: 2024-10-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study