Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2026-01-05 @ 9:16 PM
Study NCT ID:
NCT06580951
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-05
First Post:
2024-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Regenerative Peripheral Nerve Interface for Prophylaxis Against Post-Breast Surgery Pain Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Those who agree and sign the informed consent form will be randomized in 1:1 fashion (50/50 chance) to either the RPNI group or the no RPNI (Control) group. Subjects will remain blinded to their assigned study arm until their study participation has concluded.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2030-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-29', 'studyFirstSubmitDate': '2024-08-08', 'studyFirstSubmitQcDate': '2024-08-28', 'lastUpdatePostDateStruct': {'date': '2025-09-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-08-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of neuroma-related PBSPS', 'timeFrame': '12 months', 'description': "The study's primary endpoint will be the incidence of neuroma-related PBSPS, assessed by comparing the proportion of participants in each group who experience this condition during a follow-up period of 12 months, through review of electronic medical records."}], 'secondaryOutcomes': [{'measure': 'Quality of Life change', 'timeFrame': '12 months', 'description': "This endpoint will be evaluated through use of the Breast-Q questionnaires.The Breast-Q questionnaire is a type of standardized patient-reported outcomes form. There is no overall or total BREAST-Q score, only scores for each independent scale. All BREAST-Q scales are transformed into scores that range from 0-100. The scores are computed by adding the response items together and then converting the raw sum scale score to a score from 0-100. For all BREAST-Q scales, a higher score means greater satisfaction or better QOL (depending on the scale). If missing data is less than 50% of the scale's items, study team will use the mean of the completed items. Study team will convert the raw summed scale score into a score from 0 (worst) to 100 (best)."}, {'measure': 'Safety and Adverse Events', 'timeFrame': '12 months', 'description': 'The electronic medical record will be reviewed and any safety or adverse events adjudicated and recorded.'}, {'measure': 'Pain change', 'timeFrame': '12 months', 'description': "Pain Distribution is a peer-reviewed survey that provides a visual reference of various pain distributions of common pathologies affecting the breast, chest, back, and upper extremities, including neuroma-related breast pain, which will allow delineation of the specific etiology causing the patient's pain. For each of the regions surveyed (Underneath Breast, Axilla/Armpit, Radiatin from Chest to Arm, Upper Outer Shoulder, Anterior Shoulder and Axilla/Armpit, Posterior Neck and Shoulder, Posterior Neck Radiating to Arm, Shoulder Blade/Scapula) subjects indicate pain severity and frequency. There is no overall score for the entire survey. The pain severity scale ranges from 0-10. Zero (0) indicates no pain (best), and 10 (ten) indicates the worst pain imaginable (worst). The pain frequency scale ranges from \\<1 day/week (best) to 7 days/week (worst)."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Post-mastectomy Pain Syndrome']}, 'descriptionModule': {'briefSummary': "Regenerative peripheral nerve interface (RPNI) was first developed in 2012 by Dr. Paul Cederna at the University of Michigan as a means for amputees to control their prothesis with their minds. In the decade that followed, it was found RPNI surgery not only provided amputees with neuroma (a growth made up nerve tissue) pain relief but could help prevent neuroma from developing as well.\n\nThis single center, randomized controlled, investigator-initiated study will look at whether the RPNI, a nerve burying procedure involving protecting sensory nerves with a small piece of the patient's pectoralis muscle, performed at the time of the standard mastectomy with immediate breast reconstruction surgery can prevent and/or reduce the risk for long-term nerve pain after breast cancer surgery (also called neuroma-related post-breast surgery pain syndrome (PBSPS)) versus the standard surgery alone (Control group). Symptoms of PBSPS include discomfort, numbness, tingling, and shooting pain in the chest and breast area. It is relatively common and may have many causes.\n\nAbout 200 adult females (18-65 years old) who are scheduled to undergo mastectomy with immediate breast reconstruction surgery will be approached for this study. Those who agree and sign the informed consent form will be randomized in 1:1 fashion (50/50 chance) to either the RPNI group or the no RPNI (Control) group. Study participants will complete self-reported surveys (pre-surgery and at Months 1, 3, 6, and 12 post-surgery) designed to measure pain levels, quality of life, and function before and after surgery. Study participation will last approximately 12 months. Subjects will remain blinded to their assigned study arm until their study participation has concluded."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Recruitment is limited to females as virtually all cases of breast cancer, and associated mastectomy and reconstruction procedures, are in women.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Adult female 18 to 65 years of age.\n2. Undergoing breast mastectomy with immediate reconstruction.\n3. Able to provide informed consent and comply with study procedures.\n\nExclusion Criteria:\n\n1. History of chronic pain syndrome unrelated to breast surgery.\n2. Unwillingness or inability to comply with the study's follow-up requirements.\n3. Cognitive impairment or language barriers preventing proper understanding of study procedures and assessments.\n4. Participation in other interventional trials or treatments aimed at pain management that could confound study outcomes as determined by the PI.\n5. Other medical or surgical contraindication to the involved procedure (RPNI) as determined by the PI."}, 'identificationModule': {'nctId': 'NCT06580951', 'briefTitle': 'Regenerative Peripheral Nerve Interface for Prophylaxis Against Post-Breast Surgery Pain Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Rush University Medical Center'}, 'officialTitle': 'Regenerative Peripheral Nerve Interface for Prophylaxis Against Post-Breast Surgery Pain', 'orgStudyIdInfo': {'id': '24042301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RPNI', 'description': 'Subjects will complete BREAST-Q Pre-Op (Qol) survey and Pain Distribution survey prior to Surgery. Subjects will in the RPNI arm will undergo mastectomy with breast reconstruction surgery with regenerative peripheral nerve interface. Subjects will complete BREAST-Q Post-Op (QoL) survey and Pain Distribution Survey at Months 1, 3, 6, and 12 post-surgery. Information about the patient and course of care will be collected from electronic medical records.', 'interventionNames': ['Procedure: Regenerative Peripheral Nerve Interface']}, {'type': 'NO_INTERVENTION', 'label': 'No RPNI (Control)', 'description': 'Subjects will complete BREAST-Q Pre-Op (Qol) survey and Pain Distribution survey prior to Surgery. Subjects undergo mastectomy with breast reconstruction surgery without regenerative peripheral nerve interface. Subjects will complete BREAST-Q Post-Op (QoL) survey and Pain Distribution Survey at Months 1, 3, 6, and 12 post-surgery. Information about the patient and course of care will be collected from electronic medical records.'}], 'interventions': [{'name': 'Regenerative Peripheral Nerve Interface', 'type': 'PROCEDURE', 'description': 'The RPNI portion of the case will consist of blunt dissection of the cut sensory branches of the intercostal nerves at the T3 and/or T4 levels, with creation of a peripheral nerve interface using a small cuff of dissected pectoralis muscle and 3-0 Monocryl suture. The breast reconstruction will otherwise be performed as per standard protocol.', 'armGroupLabels': ['RPNI']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Research Administrator', 'role': 'CONTACT', 'email': 'anna_t_alecci@rush.edu', 'phone': '312-942-5500'}], 'overallOfficials': [{'name': 'George Kokosis, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rush University Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'George Kokosis', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'George Kokosis', 'investigatorAffiliation': 'Rush University Medical Center'}}}}