A Study on Pain After Breast Reconstruction

Memorial Sloan Kettering Cancer Center (MSK)

Status: Enrolling

Conditions: Breast Reconstruction; Postmastectomy Pain; Mastectomy; Mastectomy and Breast Reconstruction; Breast Reconstruction After Mastectomy; Mastectomy Patient

Treatments: Behavioral: PROMIS Scale v2.0 - Nociceptive Pain Quality 5a; Behavioral: PROMIS 29+2; Behavioral: PROMIS Scale v2.0 - Neuropathic Pain Quality 5a; Behavioral: PROMIS Scale v2.0 - Pain Intensity 3a

Study type: Interventional

Funder types: Other

Identifiers

NCT06627582

24-271

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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500 participants in 1 patient group

Postmastectomy Reconstruction Participants

Experimental group

Description:

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

Treatment:

Behavioral: PROMIS Scale v2.0 - Pain Intensity 3a

Behavioral: PROMIS Scale v2.0 - Neuropathic Pain Quality 5a

Behavioral: PROMIS 29+2

Behavioral: PROMIS Scale v2.0 - Nociceptive Pain Quality 5a