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

Phase 2RecruitingNCT05156060

Natalie Lockney64 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Head and Neck Cancer Locally Advanced Head and Neck Carcinoma

Interventions

GabapentinDRUG

Taken by mouth 3 times per day

KetamineDRUG

Administered intranasally 3 times per day

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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

Locations (1)

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

RECRUITING

Outcomes

Primary Outcomes

Establish the maximum tolerated dose of ketamine in combination with gabapentin (per Common Terminology Criteria for Adverse Events Criteria 4.0)

Up to a maximum planned dose of 40 mg three times a day

Time frame: Approximately 28 days (Phase I)

Count of participants with adverse events (Common Terminology Criteria for Adverse Events Criteria 4.0)

Number of Participants With Grade 3 or 4 Adverse Events

Time frame: Up to 30 post-treatment (Phase II)

Central Contacts

Vanderbilt-Ingram Service for Timely Access

CONTACT

800-811-8480 cip@vumc.org

Data from ClinicalTrials.gov

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