Recruiting

Gabapentin

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT07308717

Conditions

Breast Cancer

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Modification to Pre-operative Order Set

Study Details

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.

Conditions

Breast Cancer

Study ID

NCT07308717

Start date

Dec 16, 2025

Status verified date

Dec, 2025

Completion date

Dec 16, 2027

Anticipated

Primary completion date

Dec 16, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1896 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Control Arm

Standard of care

experimental: Intervention Arm

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

Interventions

Modification to Pre-operative Order Set

Modification to the pre-operative order set to remove gabapentin

Primary outcome measure

  • Amount of postoperative morphine milligram equivalents/MMEs required after mastectomy [ Time Frame: Up to 46 months ]

Central Contacts and Locations

Central contacts

James Flory, MD

646-608-2914floryj@mskcc.org

Andrew Vickers, PhD

646-227-3678vickersa@MSKCC.ORG

Locations

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

James Flory, MD

646-608-2684

Memorial Sloan Kettering Monmouth (Limited protocol activities)

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

James Flory, MD

646-608-2684

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

James Flory, MD

646-608-2684

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

Recruiting

Commack, New York, United States, 11725

Contacts

James Flory, MD

646-608-2684

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Recruiting

Harrison, New York, United States, 10604

Contacts

James Flory, MD

646-608-2684

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

James Flory, MD

646-608-2684

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Recruiting

Uniondale, New York, United States, 11553

Contacts

James Flory, MD

646-608-2684

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Dec 30, 2025

Last verified

Dec, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2025-12-30.