Gabapentin & Ketamine for Prevention/Treatment of Acute/Chronic Pain in Locally Advanced Head and Neck Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Gabapentin, Ketamine.
- Who it may be relevant to
- Registry conditions: Head and Neck Cancer, Locally Advanced Head and Neck Carcinoma. Basic parameters: from 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
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.
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
Interventions
- Drug Gabapentin
Taken by mouth 3 times per day - Drug Ketamine
Administered intranasally 3 times per day
Primary outcome measures
- Establish the maximum tolerated dose of ketamine in combination with gabapentin (per Common Terminology Criteria for Adverse Events Criteria 4.0) [Time frame: Approximately 28 days (Phase I)]
- Count of participants with adverse events (Common Terminology Criteria for Adverse Events Criteria 4.0) [Time frame: Up to 30 post-treatment (Phase II)]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Vanderbilt-Ingram Cancer Center — Nashville
Identifiers
NCT: NCT05156060 · VICC HNP 2173