RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2022-01-24
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05156060

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Histologically proven cancer of the head and neck cancer
  2. * Locally advanced non-metastatic disease (T3N0M0, T4N0M0, T1-4N1-3M0)
  3. * Planned primary or adjuvant radiation or chemoradiation therapy
  4. * Willing and able to provide informed consent
  5. * ECOG PS 0-2
  6. * Age ≥ 21 years
  7. * English speaking
  1. * Currently on gabapentin or ketamine
  2. * Prior non-tolerance of gabapentin or ketamine
  3. * Unable to administer ketamine intranasally due to anatomical restrictions
  4. * History of seizure disorder
  5. * History of schizophrenia
  6. * History of increased intracranial pressure
  7. * Glomerular filtration rate \<30 mL/min/1.73 m2

Contacts and Locations

Study Contact

Vanderbilt-Ingram Service for Timely Access
CONTACT
800-811-8480
cip@vumc.org

Principal Investigator

Natalie Lockney, MD
PRINCIPAL_INVESTIGATOR
Vanderbilt-Ingram Cancer Center

Study Locations (Sites)

Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232
United States

Collaborators and Investigators

Sponsor: Natalie Lockney

  • Natalie Lockney, MD, PRINCIPAL_INVESTIGATOR, Vanderbilt-Ingram Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-01-24
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2022-01-24
Study Completion Date2026-12-31

Terms related to this study

Additional Relevant MeSH Terms

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