- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04530526
Surgical Treatment of Post-surgical Mastectomy Pain Utilizing the Regenerative Peripheral Nerve Interface (RPNI)
October 25, 2023 updated by: University of Michigan Rogel Cancer Center
Surgical Treatment of Post-surgical Mastectomy Pain Utilizing the Regenerative Peripheral Nerve Interface (RPNI)
Post-mastectomy pain due to nerve injury leads to long-term opioid use and diminished quality-of-life.
The investigators on this study will evaluate the regenerative peripheral nerve interface (RPNI), a novel surgical approach to neuroma treatment, to improve patient-reported post-mastectomy pain and definitively treat intercostal neuromas after mastectomy.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Up to 40% of patients who undergo mastectomy suffer from chronic pain, defined as pain lasting greater than three months.
Chronic post-mastectomy pain due to nerve injury leads to long-term opioid use and diminished quality-of-life.
A novel surgical approach to neuroma treatment, the regenerative peripheral nerve interface (RPNI) developed to treat painful neuromas associated with limb amputation has shown significant reductions in patient-reported pain.
RPNI surgery is now available through Michigan Medicine's Multi-Disciplinary Peripheral Nerve (MDPN) Clinic to improve post-mastectomy pain and definitively treat intercostal neuromas following mastectomy.
Using patient-reported outcomes and clinical data the investigators will evaluate the use of RPNI surgery to reduce persistent post- mastectomy pain in women seeking surgical consultation through the Plastic Surgery or MDPN clinics.
Study Type
Interventional
Enrollment (Actual)
25
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Michigan
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Ann Arbor, Michigan, United States, 48109
- University of Michigan Rogel Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Reporting post-mastectomy pain at least six months removed from mastectomy or partial mastectomy (lumpectomy).
- Willing to comply with all study procedures and be available for the duration of the study
- Fluent in English
- Women of reproductive potential must use highly effective contraception (specify methods of contraception acceptable for the study, e.g., licensed hormonal methods) and/or willingness to undergo a pregnancy test.
Exclusion Criteria:
A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Previous surgical management for chronic post-mastectomy pain
- Signs/symptoms which are not suggestive of neuropathic pain based on physical exam at time of consultation.
- Pregnancy or lactation
- Men will not be enrolled in this study due to the low prevalence of male mastectomy.
- Anything that, in the opinion of the investigator, would place the subject at increased risk or preclude the subject's full compliance with or completion of the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Regenerative Peripheral Nerve Interface (RPNI)
Using evaluative ultrasound measurements and a standard panel of patient-reported outcome measures (PROMs) to measure pain experience, anxiety and depression, patients will be evaluated at baseline (T1=0months), pre-operatively following 3 months of standard neuropathic pain management therapy (T2=3months) and at three months (T3=6months) and nine months (T4=12months) post RPNI surgery.
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The regenerative peripheral nerve interface (RPNI) has emerged as a novel strategy to treat neuromas in peripheral nerves.
The RPNI consists of the residual peripheral nerve end implanted in a skeletal muscle graft, following surgical resection of the injured terminal nerve portion (neuroma).
The free muscle graft is separated from its native nerve innervation, leaving open neuromuscular junctions for ingrowth and attachment of nerve fibers from the implanted nerve.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in pain level
Time Frame: Baseline to 12 - 24 months
|
The use of RPNI surgery to reduce post-mastectomy pain will be evaluated by validated patient-reported outcome (PRO) surveys administered at 4 timepoints: at baseline (at time of enrollment), at the RPNI pre-operative visit (approximately 3 months after enrollment), and at approximately 3 and 9 months after RPNI surgery.
The average time of study involvement for each patient will be 12 months.
Patients enrolled during the first year of the study's 2-year recruitment period may be followed until the study stops.
|
Baseline to 12 - 24 months
|
Change in depression/anxiety scores
Time Frame: Baseline to 12 - 24 months
|
Evaluated by validated patient-reported outcome (PRO) surveys administered at 4 timepoints: at baseline (at time of enrollment), at the RPNI pre-operative visit (approximately 3 months after enrollment), and at approximately 3 and 9 months after RPNI surgery.
The average time of study involvement for each patient will be 12 months.
Patients enrolled during the first year of the study's 2-year recruitment period may be followed until the study stops.
|
Baseline to 12 - 24 months
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Change in opioid consumption
Time Frame: Baseline to 12 - 24 months
|
Evaluated by validated patient-reported outcome (PRO) surveys administered at 4 timepoints: at baseline (at time of enrollment), at the RPNI pre-operative visit (approximately 3 months after enrollment), and at approximately 3 and 9 months after RPNI surgery.
The average time of study involvement for each patient will be 12 months.
Patients enrolled during the first year of the study's 2-year recruitment period may be followed until the study stops.
|
Baseline to 12 - 24 months
|
Freedom from neuroma recurrence evaluated by physical exam
Time Frame: Up to 24 months
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Data will be derived from standard clinical care for patients seeking surgical management of post-mastectomy chronic pain.
Physical examinations will be performed at the time of patient enrollment and subsequent follow-up visits, as part of routine clinical evaluation, up to approximately 9 months after RPNI surgery.
Patients enrolled during the first year of the study's 2-year recruitment period may be followed until the study stops.
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Up to 24 months
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Freedom from neuroma recurrence evaluated by ultrasound
Time Frame: Up to 24 months
|
Data will be derived from standard clinical care for patients seeking surgical management of post-mastectomy chronic pain.
Ultrasound will be performed at the time of patient enrollment and subsequent follow-up visits, as part of routine clinical evaluation, up to approximately 9 months after RPNI surgery.
Patients enrolled during the first year of the study's 2-year recruitment period may be followed until the study stops.
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Up to 24 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: David L Brown, M.D., University of Michigan
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 12, 2019
Primary Completion (Actual)
June 30, 2023
Study Completion (Actual)
September 30, 2023
Study Registration Dates
First Submitted
August 24, 2020
First Submitted That Met QC Criteria
August 24, 2020
First Posted (Actual)
August 28, 2020
Study Record Updates
Last Update Posted (Actual)
October 30, 2023
Last Update Submitted That Met QC Criteria
October 25, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UMCC 2018.124
- HUM00149189 (Other Identifier: University of Michigan)
- R21CA234760 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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