Back to resultsGabapentin & Ketamine for Prevention/Treatment of Acute/Chronic Pain in Locally Advanced Head and Neck Cancer
Primary Purpose
Head and Neck Cancer, Locally Advanced Head and Neck Carcinoma
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Gabapentin
Ketamine
Sponsored by
About this trial
This is an interventional treatment trial for Head and Neck Cancer
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
Sites / Locations
- Vanderbilt-Ingram Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Gabapentin plus Ketamine
Arm Description
Gabapentin and Ketamine will be taken 3 times per day.
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05156060
Brief Title
Gabapentin & Ketamine for Prevention/Treatment of Acute/Chronic Pain in Locally Advanced Head and Neck Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 24, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Natalie Lockney
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer, Locally Advanced Head and Neck Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Gabapentin plus Ketamine
Arm Type
Experimental
Arm Description
Gabapentin and Ketamine will be taken 3 times per day.
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Other Intervention Name(s)
Neurontin
Intervention Description
Taken by mouth 3 times per day
Intervention Type
Drug
Intervention Name(s)
Ketamine
Other Intervention Name(s)
Ketalar
Intervention Description
Administered intranasally 3 times per day
Primary Outcome Measure Information:
Title
Establish the maximum tolerated dose of ketamine in combination with gabapentin (per Common Terminology Criteria for Adverse Events Criteria 4.0)
Description
Up to a maximum planned dose of 40 mg three times a day
Time Frame
Approximately 28 days (Phase I)
Title
Count of participants with adverse events (Common Terminology Criteria for Adverse Events Criteria 4.0)
Description
Number of Participants With Grade 3 or 4 Adverse Events
Time Frame
Up to 30 post-treatment (Phase II)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vanderbilt-Ingram Service for Timely Access
Phone
800-811-8480
Email
cip@vumc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dianne Lou, MD, PhD
Organizational Affiliation
Vanderbilt-Ingram Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt-Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanderbilt-Ingram Service for Timely Access
Phone
800-811-8480
Email
cip@vumc.org
First Name & Middle Initial & Last Name & Degree
Dianne Lou, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Gabapentin & Ketamine for Prevention/Treatment of Acute/Chronic Pain in Locally Advanced Head and Neck Cancer
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