Understanding pain after breast reconstruction surgery
Persistent Postmastectomy Pain: Defining the Burden of Disease and the Role of Surgical Reinnervation in Patients With Breast Reconstruction
This study is testing if a new type of surgery can help reduce ongoing pain in people who have had breast cancer surgery and reconstruction.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Locations | 7 sites (Basking Ridge, New Jersey and 6 other locations) |
| Trial ID | NCT06627582 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the prevalence of persistent postmastectomy pain (PPMP) in individuals who have undergone mastectomy and breast reconstruction due to breast cancer. It will also evaluate the effectiveness of regenerative peripheral nerve interface (RPNI) surgery in alleviating neuropathic pain associated with PPMP. Participants will be assessed using various PROMIS scales to measure pain intensity and quality. The study is conducted at Memorial Sloan Kettering Cancer Center, focusing on patients who meet specific eligibility criteria.
Who should consider this trial
Good fit: Ideal candidates are females aged 18 and older who have a history of mastectomy and breast reconstruction for breast cancer.
Not a fit: Patients who have had exchange or revision surgery within the last 6 months or have active medical reasons for pain may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for patients undergoing breast reconstruction after mastectomy.
How similar studies have performed: Other studies have explored pain management after breast reconstruction, but the specific approach of using RPNI surgery for PPMP is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Basking Ridge, New Jersey and 6 other locations
- Memoral Sloan Kettering Basking Ridge (Limited Protocol Activities) — Basking Ridge, New Jersey, United States (Recruiting)
- Memoral Sloan Kettering Monmouth (Limited protocol activities) — Middletown, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity) — Commack, New York, United States (Recruiting)
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison, New York, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center (All protocol activites) — New York, New York, United States (Recruiting)
- Memorial Sloan Kettering Nassau (Limited Protocol Activites) — Rockville Centre, New York, United States (Recruiting)
Study contacts
- Principal investigator: Danielle Rochlin, MD — Memorial Sloan Kettering Cancer Center
- Study coordinator: Danielle Rochlin, MD
- Email: rochlind@mskcc.org
- Phone: 646-608-8033
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.