Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06627582

A Study on Pain After Breast Reconstruction

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Memoral Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PROMIS Scale v2.0 - Pain Intensity 3a

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

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

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

Behavioral

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

Primary outcomes

  1. Number of participants with Persistent Postmastectomy Pain

    Time frame: up to 6 months

    The primary objective is to estimate the prevalence of Persistent Postmastectomy Pain/PPMP in breast cancer survivors treated with mastectomy and reconstruction.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

Persistent Postmastectomy Pain: Defining the Burden of Disease and the Role of Surgical Reinnervation in Patients With Breast Reconstruction

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Oct 4, 2024
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.