A Study on Pain After Breast Reconstruction

Not Applicable

Recruiting

• Conditions: Mastectomy Patient; Mastectomy; Mastectomy and Breast Reconstruction; Breast Reconstruction; Breast Reconstruction After Mastectomy; Postmastectomy Pain
• Interventions: Behavioral: PROMIS Scale v2.0 - Pain Intensity 3a; Behavioral: PROMIS 29+2; Behavioral: PROMIS Scale v2.0 - Nociceptive Pain Quality 5a; Behavioral: PROMIS Scale v2.0 - Neuropathic Pain Quality 5a

• Registration Number: NCT06627582
• Lead 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-10-01
• Study First Submitted: 2024-10-02
• Study First Submitted QC: 2024-10-02
• Study First Posted: 2024-10-04
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-22
• Primary Completion: 2027-10-01
• Study Completion: 2027-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Postmastectomy Reconstruction Participants	PROMIS Scale v2.0 - Pain Intensity 3a	Participants will be postmastectomy reconstruction and \>/= 6 months postoperative
Postmastectomy Reconstruction Participants	PROMIS 29+2	Participants will be postmastectomy reconstruction and \>/= 6 months postoperative
Postmastectomy Reconstruction Participants	PROMIS Scale v2.0 - Nociceptive Pain Quality 5a	Participants will be postmastectomy reconstruction and \>/= 6 months postoperative
Postmastectomy Reconstruction Participants	PROMIS Scale v2.0 - Neuropathic Pain Quality 5a	Participants will be postmastectomy reconstruction and \>/= 6 months postoperative

Primary Outcome Measures

Name	Time	Method
Number of participants with Persistent Postmastectomy Pain	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.

Trial Locations

Locations (7)

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

Memoral Sloan Kettering Monmouth (Limited protocol activities); 🇺🇸 Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities); 🇺🇸 Montvale, New Jersey, United States

Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity); 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities); 🇺🇸 Harrison, New York, United States

Memorial Sloan Kettering Cancer Center (All protocol activites); 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Nassau (Limited Protocol Activites); 🇺🇸 Rockville Centre, New York, United States