NCT07308717

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,896

participants targeted

Target at P75+ for phase_4 breast-cancer

Timeline
19mo left

Started Dec 2025

Geographic Reach
1 country

7 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress22%
Dec 2025Dec 2027

Study Start

First participant enrolled

December 16, 2025

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

December 17, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 30, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 16, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2027

Last Updated

December 30, 2025

Status Verified

December 1, 2025

Enrollment Period

2 years

First QC Date

December 17, 2025

Last Update Submit

December 17, 2025

Conditions

Breast Cancer

Keywords

Breast cancerunilateral mastectomybilateral mastectomy25-183Memorial Sloan Kettering Cancer Center

Outcome Measures

Primary Outcomes (1)

  • Amount of postoperative morphine milligram equivalents/MMEs required after mastectomy

    Determine the effect of peri-operative gabapentin use on pain control in the PACU operationalized as the top quartile of postoperative morphine milligram equivalents/MMEs required in participants undergoing mastectomy

    Up to 46 months

Study Arms (2)

Control Arm

NO INTERVENTION

Standard of care

Intervention Arm

EXPERIMENTAL

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

Other: Modification to Pre-operative Order Set

Interventions

Modification to Pre-operative Order SetOTHER

Modification to the pre-operative order set to remove gabapentin

Intervention Arm

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920, United States

RECRUITING

Memorial Sloan Kettering Monmouth (Limited protocol activities)

Middletown, New Jersey, 07748, United States

RECRUITING

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645, United States

RECRUITING

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

Commack, New York, 11725, United States

RECRUITING

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, 10604, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, 11553, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • James Flory, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

James Flory, MD

CONTACT

646-608-2914floryj@mskcc.org

Andrew Vickers, PhD

CONTACT

646-227-3678vickersa@MSKCC.ORG

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2025

First Posted

December 30, 2025

Study Start

December 16, 2025

Primary Completion (Estimated)

December 16, 2027

Study Completion (Estimated)

December 16, 2027

Last Updated

December 30, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Locations

US(7)