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NCT06627582 | RECRUITING | Mastectomy

A Study on Pain After Breast Reconstruction
Sponsor:

Memorial Sloan Kettering Cancer Center

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.

Condition or disease

Mastectomy

Mastectomy Patient

Mastectomy and Breast Reconstruction

Breast Reconstruction

Breast Reconstruction After Mastectomy

Postmastectomy Pain

Intervention/treatment

PROMIS Scale v2.0 - Pain Intensity 3a

PROMIS 29+2

PROMIS Scale v2.0 - Nociceptive Pain Quality 5a

PROMIS Scale v2.0 - Neuropathic Pain Quality 5a

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 500 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Persistent Postmastectomy Pain: Defining the Burden of Disease and the Role of Surgical Reinnervation in Patients With Breast Reconstruction
Actual Study Start Date : 2024-10-01
Estimated Primary Completion Date : 2027-10-01
Estimated Study Completion Date : 2027-10-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: 1
Criteria
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
A Study on Pain After Breast Reconstruction

Location Details

NCT06627582

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, New Jersey

Memoral Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, United States, 07920

RECRUITING

United States, New Jersey

Memoral Sloan Kettering Monmouth (Limited protocol activities)

Middletown, New Jersey, United States, 07748

RECRUITING

United States, New Jersey

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, United States, 07645

RECRUITING

United States, New York

Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)

Commack, New York, United States, 11725

RECRUITING

United States, New York

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, United States, 10604

RECRUITING

United States, New York

Memorial Sloan Kettering Cancer Center (All protocol activites)

New York, New York, United States, 10065

RECRUITING

United States, New York

Memorial Sloan Kettering Nassau (Limited Protocol Activites)

Rockville Center, New York, United States, 11553