Clinical trial NCT04530526: Surgical Treatment of Post-surgical Mastectomy Pain Utilizing the Regenerative Peripheral Nerve Interface
Official title: Surgical Treatment of Post-surgical Mastectomy Pain Utilizing the Regenerative Peripheral Nerve Interface (RPNI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-Mastectomy Chronic Pain Syndrome
Keywords: neuroma,outcome-assessment health care, post-mastectomy
outcome-assessment health care
post-mastectomy
neuroma
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-08-28
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in pain level
timeFrame: Baseline to 12 - 24 months
measure: Change in depression/anxiety scores
timeFrame: Baseline to 12 - 24 months
measure: Change in opioid consumption
timeFrame: Baseline to 12 - 24 months
measure: Freedom from neuroma recurrence evaluated by physical exam
timeFrame: Up to 24 months
measure: Freedom from neuroma recurrence evaluated by ultrasound
timeFrame: Up to 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Rogel Cancer Center
state: Michigan
Study officials:
affiliation: University of Michigan
name: David L Brown, M.D.
role: PRINCIPAL_INVESTIGATOR
References: