Back to resultsSurgical Treatment of Post-surgical Mastectomy Pain Utilizing the Regenerative Peripheral Nerve Interface (RPNI)
Primary Purpose
Post-Mastectomy Chronic Pain Syndrome
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Regenerative Peripheral Nerve Interface
Sponsored by
About this trial
This is an interventional treatment trial for Post-Mastectomy Chronic Pain Syndrome focused on measuring neuroma,outcome-assessment health care, post-mastectomy, outcome-assessment health care, post-mastectomy, neuroma
Eligibility Criteria
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.
Sites / Locations
- University of Michigan Rogel Cancer Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Regenerative Peripheral Nerve Interface (RPNI)
Arm Description
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.
Outcomes
Primary Outcome Measures
Change in pain level
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.
Change in depression/anxiety scores
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.
Change in opioid consumption
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.
Freedom from neuroma recurrence evaluated by physical exam
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.
Freedom from neuroma recurrence evaluated by ultrasound
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04530526
First Posted
August 24, 2020
Last Updated
August 29, 2023
Sponsor
University of Michigan Rogel Cancer Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT04530526
Brief Title
Surgical Treatment of Post-surgical Mastectomy Pain Utilizing the Regenerative Peripheral Nerve Interface
Acronym
RPNI
Official Title
Surgical Treatment of Post-surgical Mastectomy Pain Utilizing the Regenerative Peripheral Nerve Interface (RPNI)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 12, 2019 (Actual)
Primary Completion Date
June 30, 2023 (Actual)
Study Completion Date
September 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Michigan Rogel Cancer Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Mastectomy Chronic Pain Syndrome
Keywords
neuroma,outcome-assessment health care, post-mastectomy, outcome-assessment health care, post-mastectomy, neuroma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Regenerative Peripheral Nerve Interface (RPNI)
Arm Type
Other
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Regenerative Peripheral Nerve Interface
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in pain level
Description
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.
Time Frame
Baseline to 12 - 24 months
Title
Change in depression/anxiety scores
Description
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.
Time Frame
Baseline to 12 - 24 months
Title
Change in opioid consumption
Description
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.
Time Frame
Baseline to 12 - 24 months
Title
Freedom from neuroma recurrence evaluated by physical exam
Description
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.
Time Frame
Up to 24 months
Title
Freedom from neuroma recurrence evaluated by ultrasound
Description
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.
Time Frame
Up to 24 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David L Brown, M.D.
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Rogel Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Surgical Treatment of Post-surgical Mastectomy Pain Utilizing the Regenerative Peripheral Nerve Interface
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