Clinical trial · Interventional
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
NCT06627582CI-TRIAL-00106571active not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Reconstruction | — | UNRESOLVED | — |
| Breast Reconstruction After Mastectomy | — | UNRESOLVED | — |
| Mastectomy | — | UNRESOLVED | — |
| Mastectomy and Breast Reconstruction | — | UNRESOLVED | — |
| Mastectomy Patient | — | UNRESOLVED | — |
| Postmastectomy Pain | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PROMIS 29+2 | Behavioral | — | UNRESOLVED |
| PROMIS Scale v2.0 - Neuropathic Pain Quality 5a | Behavioral | — | UNRESOLVED |
| PROMIS Scale v2.0 - Nociceptive Pain Quality 5a | Behavioral | — | UNRESOLVED |
| PROMIS Scale v2.0 - Pain Intensity 3a | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Postmastectomy Reconstruction Participants
- description
- Participants will be postmastectomy reconstruction and \>/= 6 months postoperative
- interventionNames
- 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
Primary outcomes (1)
- measure
- Number of participants with Persistent Postmastectomy Pain
- timeFrame
- up to 6 months
- description
- The primary objective is to estimate the prevalence of Persistent Postmastectomy Pain/PPMP in breast cancer survivors treated with mastectomy and reconstruction.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.