A Study on Pain After Breast Reconstruction

NCT ID: NCT06627582

Last Updated: 2025-07-01

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

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-01

Study Completion Date

2027-10-01

Brief Summary

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The purpose of this study is to find out how common persistent postmastectomy pain (PPMP) is among people who have had a mastectomy and breast reconstruction surgery for their breast cancer. The study will also look at how effective regenerative peripheral nerve interface (RPNI) surgery is for reducing pain from neuropathic PPMP after breast reconstruction.

Detailed Description

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Conditions

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Mastectomy Mastectomy Patient Mastectomy and Breast Reconstruction Breast Reconstruction Breast Reconstruction After Mastectomy Postmastectomy Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Postmastectomy Reconstruction Participants

Participants will be postmastectomy reconstruction and \>/= 6 months postoperative

Group Type EXPERIMENTAL

PROMIS Scale v2.0 - Pain Intensity 3a

Intervention Type BEHAVIORAL

PROMIS Scale v2.0 - Pain Intensity 3a is a 3-question short form in which patients rate their worst, average, and current level of pain during the past 7 days.

PROMIS 29+2

Intervention Type BEHAVIORAL

PROMIS 29+2 (PROMIS-Preference, PROPr) is a compilation of item banks to assess pain intensity

PROMIS Scale v2.0 - Nociceptive Pain Quality 5a

Intervention Type BEHAVIORAL

5-question short form that identifies patients who have experienced nociceptive pain during the past 7 days

PROMIS Scale v2.0 - Neuropathic Pain Quality 5a

Intervention Type BEHAVIORAL

5-question short form that identifies patients who have experienced neuropathic pain during the past 7 days

Interventions

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PROMIS Scale v2.0 - Pain Intensity 3a

PROMIS Scale v2.0 - Pain Intensity 3a is a 3-question short form in which patients rate their worst, average, and current level of pain during the past 7 days.

Intervention Type BEHAVIORAL

PROMIS 29+2

PROMIS 29+2 (PROMIS-Preference, PROPr) is a compilation of item banks to assess pain intensity

Intervention Type BEHAVIORAL

PROMIS Scale v2.0 - Nociceptive Pain Quality 5a

5-question short form that identifies patients who have experienced nociceptive pain during the past 7 days

Intervention Type BEHAVIORAL

PROMIS Scale v2.0 - Neuropathic Pain Quality 5a

5-question short form that identifies patients who have experienced neuropathic pain during the past 7 days

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Female
* Age ≥18 years
* History of mastectomy for breast cancer or genetic predisposition to breast cancer
* History of breast reconstruction with implants and/or autologous tissue
* At least 6 months of follow-up after reconstruction
* Patient treated at MSK

Exclusion Criteria

* Exchange or revision surgery within 6 months
* Active medical reason for pain (e.g., infectious, neoplastic, wound related)
* Greater than 15 years post-reconstruction
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

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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Danielle Rochlin, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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Memoral Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, United States

Site Status RECRUITING

Memoral 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 Suffolk-Commack (Limited protocol activity)

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 (All protocol activites)

New York, New York, United States

Site Status RECRUITING

Memorial Sloan Kettering Nassau (Limited Protocol Activites)

Rockville Centre, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Danielle Rochlin, MD

Role: CONTACT

646-608-8033

Babak Mahrara, MD

Role: CONTACT

646-608-8085

Facility Contacts

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Danielle Rochlin, MD

Role: primary

646-608-8033

Danielle Rochlin, MD

Role: primary

646-608-8033

Danielle Rochlin, MD

Role: primary

646-608-8033

Danielle Rochlin, MD

Role: primary

646-608-8033

Danielle Rochlin, MD

Role: primary

646-608-8033

Danielle Rochlin, MD

Role: primary

646-608-8033

Danielle Rochlin, MD

Role: primary

646-608-8033

Related Links

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http://www.mskcc.org

Memorial Sloan Kettering Cancer Center

Other Identifiers

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24-271

Identifier Type: -

Identifier Source: org_study_id

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