Breast CancerNCT07146009
Targeted Nerve Surgery for the Prevention of Post-Mastectomy Pain Syndrome: A Randomized Trial
A study testing Nerve Surgery in people with Breast Cancer, run by Advanced Reconstructive Surgery Alliance.
Trial summary
Post-Mastectomy Pain Syndrome (PMPS) is a chronic pain condition often caused by neuroma formation and nerve injury following breast cancer surgery. Standard breast reconstruction protocols typically do not address damaged intercostal nerves, leaving patients at risk for persistent nerve-related pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Nerve Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Oct 2025to 25 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (≥18 years old) undergoing second-stage implant exchange as part of tissue expander based breast reconstruction.
- Patients with no prior diagnosis of PMPS.
Who cannot join
- Prior nerve surgery in the chest region or chronic pain conditions unrelated to mastectomy.
- Recent chest radiation (<6 months), severe scarring, or active infection.
- Uncontrolled diabetes, high-dose corticosteroids, or immunosuppressive therapy.
- Psychiatric or cognitive impairments.
- Pregnancy, or active lactation.
- Autologous tissue based breast reconstruction.
- Participation in another study within 6 months or inability to comply with follow-up.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Post-Mastectomy Pain Syndrome (PMPS) is a chronic pain condition often caused by neuroma formation and nerve injury following breast cancer surgery. Standard breast reconstruction protocols typically do not address damaged intercostal nerves, leaving patients at risk for persistent nerve-related pain.
Prophylactic nerve surgery techniques, such as Targeted Muscle Reinnervation (TMR) and Regenerative Peripheral Nerve Interfaces (RPNI), offer innovative approaches to prevent neuroma formation by managing damaged nerves during surgery. This study will evaluate whether incorporating prophylactic nerve surgery during second-stage implant exchange after tissue expander based breast reconstruction can reduce the incidence of PMPS compared to standard medical therapies.
- Conditions
- Breast Cancer
- Being tested
- Nerve Surgery, Standard of Care (Investigator Choice)
- Keywords
- Post-mastectomy pain syndrome (PMPS), Breast reconstruction, Regenerative Peripheral Nerve Interfaces, Targeted Muscle Reinnervation
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nerve SurgeryProcedure or surgery
Patients undergoing prophylactic nerve surgery (RPNI) during second-stage implant exchange after tissue expander based breast reconstruction.
Standard of Care (Investigator Choice)Other
Patients receiving standard medical therapies for PMPS prevention (e.g., pharmacologic pain management, physical therapy).
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | Active comparator | Patients receiving standard medical therapies for PMPS prevention (e.g., pharmacologic pain management, physical therapy). Receives: Other: Standard of Care (Investigator Choice) |
| Nerve Surgery | Experimental | Patients undergoing prophylactic nerve surgery (RPNI) during second-stage implant exchange after tissue expander based breast reconstruction. Receives: Procedure: Nerve Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Post-Mastectomy Pain Syndrome
Incidence of PMPS, defined as persistent pain beyond 6 months postoperatively.
Measured: Pre-operative visit (baseline) to 12 months.
Secondary outcomes (2)
Breast Cancer Pain Questionnaire
Pain severity scores at 3, 6, and 12 months.
Measured: Pre-operative visit (baseline) to 12 months.
Adverse event rates
Complication and adverse event rates.
Measured: Pre-operative visit (baseline) to 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study startOct 2025 (estimated)
- Primary completionOct 2027 (estimated)
- Study completion25 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Advanced Reconstructive Surgery Alliance
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Kari Colen, Advanced Reconstructive Surgery Alliance
- Investigators
- Kari Colen, MD, Principal investigator, Advanced Reconstructive Surgery Alliance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07146009
- Sponsor's protocol ID
- R-2025.02.25.01
- Status last verified
- Aug 2025
- First submitted
- 21 Aug 2025
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Nerve Surgery for the Prevention of Post-Mastectomy Pain Syndrome: A Randomized Trial
- ClinicalTrials.gov ID
- NCT07146009
- Acronym / sponsor ID
- R-2025.02.25.01
- Conditions
- Breast Cancer
- Keywords
- Post-mastectomy pain syndrome (PMPS), Breast reconstruction, Regenerative Peripheral Nerve Interfaces, Targeted Muscle Reinnervation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Advanced Reconstructive Surgery AllianceOther government
- Study start
- Oct 2025 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- 25 Feb 2028 (estimated)
- First posted
- 28 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Post-Mastectomy Pain Syndrome (PMPS) is a chronic pain condition often caused by neuroma formation and nerve injury following breast cancer surgery. Standard breast reconstruction protocols typically do not address damaged intercostal nerves, leaving patients at risk for persistent nerve-related pain.
Prophylactic nerve surgery techniques, such as Targeted Muscle Reinnervation (TMR) and Regenerative Peripheral Nerve Interfaces (RPNI), offer innovative approaches to prevent neuroma formation by managing damaged nerves during surgery. This study will evaluate whether incorporating prophylactic nerve surgery during second-stage implant exchange after tissue expander based breast reconstruction can reduce the incidence of PMPS compared to standard medical therapies.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care | Active comparator | Other: Standard of Care (Investigator Choice)Patients receiving standard medical therapies for PMPS prevention (e.g., pharmacologic pain management, physical therapy). |
| Nerve Surgery | Experimental | Procedure: Nerve SurgeryPatients undergoing prophylactic nerve surgery (RPNI) during second-stage implant exchange after tissue expander based breast reconstruction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients (≥18 years old) undergoing second-stage implant exchange as part of tissue expander based breast reconstruction.
- Patients with no prior diagnosis of PMPS.
Key exclusion criteria (7 listed)
- Prior nerve surgery in the chest region or chronic pain conditions unrelated to mastectomy.
- Recent chest radiation (<6 months), severe scarring, or active infection.
- Uncontrolled diabetes, high-dose corticosteroids, or immunosuppressive therapy.
- Psychiatric or cognitive impairments.
- Pregnancy, or active lactation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nerve SurgeryPatients undergoing prophylactic nerve surgery (RPNI) during second-stage implant exchange after tissue expander based breast reconstruction. | Procedure or surgery | Nerve Surgery |
| Standard of Care (Investigator Choice)Patients receiving standard medical therapies for PMPS prevention (e.g., pharmacologic pain management, physical therapy). | Other | Standard of care |
Primary outcome
Incidence of Post-Mastectomy Pain Syndrome
Time frame: Pre-operative visit (baseline) to 12 months.
Incidence of PMPS, defined as persistent pain beyond 6 months postoperatively.
2 secondary outcomes
Breast Cancer Pain Questionnaire
Time frame: Pre-operative visit (baseline) to 12 months.
Adverse event rates
Time frame: Pre-operative visit (baseline) to 12 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kari Colen, MD principal investigator
Advanced Reconstructive Surgery Alliance
Questions about this trial
What is this clinical trial studying?
A study testing Nerve Surgery in people with Breast Cancer, run by Advanced Reconstructive Surgery Alliance.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Grace Wells, BS (732-741-0970 ext. 1889, gwells@sycamoremm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Post-Mastectomy Pain Syndrome (time frame: Pre-operative visit (baseline) to 12 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025.