Gabapentin & Ketamine for Prevention/Treatment of Acute/C... | NCT05156060

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

NCT05156060

Sponsor

Natalie Lockney

Status

Recruiting

Last Update Posted

Oct 21, 2024Actual

Enrollment

64Estimated

Phase

Phase 1Phase 2

Conditions

Head and Neck Cancer
Locally Advanced Head and Neck Carcinoma

Interventions

Gabapentin
Ketamine

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 24, 2022Actual

Primary Completion Date

Dec 31, 2025Estimated

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Nov 30, 2021

First Submission Date that Met QC Criteria

Nov 30, 2021

First Posted Date

Dec 14, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 17, 2024

Last Update Posted Date

Oct 21, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

64Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Gabapentin plus Ketamine	Experimental	Gabapentin and Ketamine will be taken 3 times per day.	Drug: Gabapentin Drug: Ketamine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gabapentin	Drug	Taken by mouth 3 times per day	Gabapentin plus Ketamine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)
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)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Vanderbilt-Ingram Service for Timely Access	Contact	800-811-8480		cip@vumc.org

Overall Officials

Name	Affiliation	Role
Natalie Lockney, MD	Vanderbilt-Ingram Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vanderbilt-Ingram Cancer Center	Recruiting	Nashville	Tennessee	37232	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
ICF	No	No	Yes	Informed Consent Form	Aug 22, 2021	Nov 8, 2021	ICF_000.pdf

Condition Browse Module

MeSH Terms

ID	Term
D006258	Head and Neck Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077206	Gabapentin
D007649	Ketamine

Ancestor Terms

ID	Term
D000588	Amines
D009930	Organic Chemicals
D005680	gamma-Aminobutyric Acid
D000613	Aminobutyrates

Browse Leaves

Not provided

Browse Branches

Not provided