A Study on Pain After Breast Reconstruction
Persistent Postmastectomy Pain: Defining the Burden of Disease and the Role of Surgical Reinnervation in Patients With Breast Reconstruction
1 other identifier
interventional
274
1 country
7
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2024
Typical duration for not_applicable
7 active sites
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 Start
First participant enrolled
October 1, 2024
CompletedFirst Submitted
Initial submission to the registry
October 2, 2024
CompletedFirst Posted
Study publicly available on registry
October 4, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2027
March 27, 2026
March 1, 2026
3 years
October 2, 2024
March 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of participants with Persistent Postmastectomy Pain
The primary objective is to estimate the prevalence of Persistent Postmastectomy Pain/PPMP in breast cancer survivors treated with mastectomy and reconstruction.
up to 6 months
Study Arms (1)
Postmastectomy Reconstruction Participants
EXPERIMENTALParticipants will be postmastectomy reconstruction and \>/= 6 months postoperative
Interventions
5-question short form that identifies patients who have experienced nociceptive pain during the past 7 days
5-question short form that identifies patients who have experienced neuropathic pain during the past 7 days
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 (PROMIS-Preference, PROPr) is a compilation of item banks to assess pain intensity
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Exchange or revision surgery within 6 months
- Active medical reason for pain (e.g., infectious, neoplastic, wound related)
- Greater than 15 years post-reconstruction
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Memoral Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920, United States
Memoral Sloan Kettering Monmouth (Limited protocol activities)
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center (All protocol activites)
New York, New York, 10065, United States
Memorial Sloan Kettering Nassau (Limited Protocol Activites)
Rockville Centre, New York, 11553, United States
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Danielle Rochlin, MD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 2, 2024
First Posted
October 4, 2024
Study Start
October 1, 2024
Primary Completion (Estimated)
October 1, 2027
Study Completion (Estimated)
October 1, 2027
Last Updated
March 27, 2026
Record last verified: 2026-03
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.