NCT07146009

Brief Summary

Post-Mastectomy Pain Syndrome (PMPS) is a chronic pain condition often caused by neuroma formation and nerve injury following breast cancer surgery. Standard breast reconstruction protocols typically do not address damaged intercostal nerves, leaving patients at risk for persistent nerve-related pain. Prophylactic nerve surgery techniques, such as Targeted Muscle Reinnervation (TMR) and Regenerative Peripheral Nerve Interfaces (RPNI), offer innovative approaches to prevent neuroma formation by managing damaged nerves during surgery. This study will evaluate whether incorporating prophylactic nerve surgery during second-stage implant exchange after tissue expander based breast reconstruction can reduce the incidence of PMPS compared to standard medical therapies.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
22mo left

Started Oct 2025

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress25%
Oct 2025Feb 2028

First Submitted

Initial submission to the registry

August 21, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 28, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2028

Last Updated

August 28, 2025

Status Verified

August 1, 2025

Enrollment Period

2 years

First QC Date

August 21, 2025

Last Update Submit

August 21, 2025

Conditions

Breast Cancer

Keywords

Post-mastectomy pain syndrome (PMPS)Breast reconstructionRegenerative Peripheral Nerve InterfacesTargeted Muscle Reinnervation

Outcome Measures

Primary Outcomes (1)

  • Incidence of Post-Mastectomy Pain Syndrome

    Incidence of PMPS, defined as persistent pain beyond 6 months postoperatively.

    Pre-operative visit (baseline) to 12 months.

Secondary Outcomes (2)

  • Breast Cancer Pain Questionnaire

    Pre-operative visit (baseline) to 12 months.

  • Adverse event rates

    Pre-operative visit (baseline) to 12 months.

Study Arms (2)

Standard of care

ACTIVE COMPARATOR

Patients receiving standard medical therapies for PMPS prevention (e.g., pharmacologic pain management, physical therapy).

Other: Standard of Care (Investigator Choice)

Nerve Surgery

EXPERIMENTAL

Patients undergoing prophylactic nerve surgery (RPNI) during second-stage implant exchange after tissue expander based breast reconstruction.

Procedure: Nerve Surgery

Interventions

Nerve SurgeryPROCEDURE

Patients undergoing prophylactic nerve surgery (RPNI) during second-stage implant exchange after tissue expander based breast reconstruction.

Nerve Surgery
Standard of Care (Investigator Choice)OTHER

Patients receiving standard medical therapies for PMPS prevention (e.g., pharmacologic pain management, physical therapy).

Standard of care

Eligibility Criteria

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

You may qualify if:

  • Adult patients (≥18 years old) undergoing second-stage implant exchange as part of tissue expander based breast reconstruction.
  • Patients with no prior diagnosis of PMPS.

You may not qualify if:

  • Prior nerve surgery in the chest region or chronic pain conditions unrelated to mastectomy.
  • Recent chest radiation (\<6 months), severe scarring, or active infection.
  • Uncontrolled diabetes, high-dose corticosteroids, or immunosuppressive therapy.
  • Psychiatric or cognitive impairments.
  • Pregnancy, or active lactation.
  • Autologous tissue based breast reconstruction.
  • Participation in another study within 6 months or inability to comply with follow-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Kari Colen, MD

    Advanced Reconstructive Surgery Alliance

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Grace Wells, BS

CONTACT

732-741-0970gwells@sycamoremm.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

August 21, 2025

First Posted

August 28, 2025

Study Start

October 1, 2025

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

February 25, 2028

Last Updated

August 28, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share