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

Natalie Lockney

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Locally Advanced Head and Neck Carcinoma; Head and Neck Cancer

Treatments: Drug: Ketamine; Drug: Gabapentin

Study type: Interventional

Funder types: Other

Identifiers

NCT05156060

VICC HNP 2173

Details and patient eligibility

About

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.

Full 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

Enrollment: 64 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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64 participants in 1 patient group

Gabapentin plus Ketamine

Experimental group

Description:

Gabapentin and Ketamine will be taken 3 times per day.

Treatment:

Drug: Gabapentin

Drug: Ketamine