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Gabapentin And Breast Surgery Decision Architecture Randomization Trial (GABS-DART) Protocol

NCT ID: NCT07308717

Last Updated: 2025-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

1896 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-16

Study Completion Date

2027-12-16

Brief Summary

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This study aims to assess whether gabapentin should be a standard component of peri-operative pain control in mastectomy patients at Memorial Sloan Kettering Cancer Center.

Detailed Description

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Conditions

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Breast Cancer

Keywords

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Breast cancer unilateral mastectomy bilateral mastectomy 25-183 Memorial Sloan Kettering Cancer Center

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control Arm

Standard of care

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention Arm

The study intervention will consist of modification to the pre-operative order set to remove gabapentin.

Group Type EXPERIMENTAL

Modification to Pre-operative Order Set

Intervention Type OTHER

Modification to the pre-operative order set to remove gabapentin

Interventions

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Modification to Pre-operative Order Set

Modification to the pre-operative order set to remove gabapentin

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age 18 to 65 years
* Undergoing ambulatory extended recover (AXR) mastectomy (bilateral or unilateral) at the Josie Robertson Surgical Center (JSRC)

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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James Flory, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, United States

Site Status RECRUITING

Memorial Sloan Kettering Monmouth (Limited protocol activities)

Middletown, New Jersey, United States

Site Status RECRUITING

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, United States

Site Status RECRUITING

Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities)

Commack, New York, United States

Site Status RECRUITING

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, United States

Site Status RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status RECRUITING

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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James Flory, MD

Role: CONTACT

Phone: 646-608-2914

Email: [email protected]

Andrew Vickers, PhD

Role: CONTACT

Phone: 646-227-3678

Email: [email protected]

Facility Contacts

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James Flory, MD

Role: primary

James Flory, MD

Role: primary

James Flory, MD

Role: primary

James Flory, MD

Role: primary

James Flory, MD

Role: primary

James Flory, MD

Role: primary

James Flory, MD

Role: primary

Related Links

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http://www.mskcc.org

Memorial Sloan Kettering Cancer Center

Other Identifiers

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25-183

Identifier Type: -

Identifier Source: org_study_id