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NCT05156060 | RECRUITING | Head and Neck Cancer

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

Natalie Lockney

Information provided by (Responsible Party):

Natalie Lockney

Brief 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.

Condition or disease

Head and Neck Cancer

Locally Advanced Head and Neck Carcinoma

Intervention/treatment

Gabapentin

Ketamine

Phase

PHASE1

PHASE2

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

Study Type : INTERVENTIONAL
Estimated Enrollment : 64 participants
Masking : NONE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2022-01-24
Estimated Primary Completion Date : 2025-12-31
Estimated Study Completion Date : 2026-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 21 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
Gabapentin & Ketamine for Prevention/Treatment of Acute/Chronic Pain in Locally Advanced Head and Neck Cancer

Location Details

NCT05156060

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How to Participate

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Locations

RECRUITING

United States, Tennessee

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States, 37232