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NCT05156060 Clinical Trial

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

Head and Neck Cancer Clinical Trial

Official title:
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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05156060
Other study ID # VICC HNP 2173
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date January 24, 2022
Est. completion date December 31, 2026

Study information
Verified date February 2024
Source Vanderbilt-Ingram Cancer Center
Contact Vanderbilt-Ingram Service for Timely Access
Phone 800-811-8480
Email cip@vumc.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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

Recruitment information / eligibility
Status Recruiting
Enrollment 44
Est. completion date December 31, 2026
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Gabapentin
Taken by mouth 3 times per day
• Ketamine
Administered intranasally 3 times per day

Locations
Country Name City State
United States Vanderbilt-Ingram Cancer Center Nashville Tennessee

Sponsors (1)
Lead Sponsor Collaborator
Natalie Lockney

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Approximately 28 days (Phase I)
Primary 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 Up to 30 post-treatment (Phase II)
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