Effect of Neurotization on QoL and Sensory Restoration

NCT05206565 | Withdrawn DMC

• 4 other identifiers: 2021-0290A539730UW21028Protocol Version 9/29/2021
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a single-site, randomized, double-blinded trial to assess whether neurotization following autologous breast reconstruction in patients with breast cancer increases quality of life and sensation in the breast compared to breast reconstruction without neurotization. 50 participants will be enrolled and can expect to be on study for up to 18 months after reconstruction surgery.

Conditions

Breast Reconstruction; Neurotization

Keywords

Quality of life

Outcome Measures

Primary Outcomes (1)

• Breast-Q® score in participants who have undergone autologous reconstruction with TRAM/DIEP flaps with and without neurotization

  Self-reported, breast-specific health-related QoL(Quality of life) via use of the Breast-Q® in participant with breast cancer who have undergone autologous reconstruction with TRAM/DIEP flaps with and without neurotization. This score represents questionnaires about different domains and each question has four possible dimensions. The values of these dimensions varies from 1 to 4 (Likert Scale). The sum of each domain raw score scale will be plotted in the Breast Q Conversion Table to convert the summed domain score to a Equivalent Rasch Transformed Score with values ranging from 0 (worst) to 100 (best).

  approximately 12 months after reconstruction

Secondary Outcomes (8)

• Change in Breast-Q® score in participants who have undergone autologous reconstruction with TRAM/DIEP flaps with and without neurotization

  Baseline(pre-operative), approximately 1-3 weeks, 6 weeks, 3 months, 6 months, 12 months, and 18 months after the reconstruction

• Change in Ability to Participate in Social Roles and Activities assessed by the PROMIS SF8a score in participants who have undergone autologous reconstruction with TRAM/DIEP flaps with and without neurotization

  Baseline(pre-operative), approximately 1-3 weeks, 6 weeks, 3 months, 6 months, 12 months, and 18 months after the reconstruction

• Change in Pain Interference assessed by PROMIS SF8a score in participants who have undergone autologous reconstruction with TRAM/DIEP flaps with and without neurotization

  Baseline(pre-operative), approximately 1-3 weeks, 6 weeks, 3 months, 6 months, 12 months, and 18 months after the reconstruction

• Change in PROMIS Psychosocial Illness Impact-Positive SF8a score in participants who have undergone autologous reconstruction with TRAM/DIEP flaps with and without neurotization

  Baseline(pre-operative), approximately 1-3 weeks, 6 weeks, 3 months, 6 months, 12 months, and 18 months after the reconstruction

• Change in PROMIS Psychosocial Illness Impact-Negative SF8a score in participants who have undergone autologous reconstruction with TRAM/DIEP flaps with and without neurotization

  Baseline(pre-operative), approximately 1-3 weeks, 6 weeks, 3 months, 6 months, 12 months, and 18 months after the reconstruction

Study Arms (2)

Autologous with TRAM/DIEP flaps, with neurotization

EXPERIMENTAL

Autologous with TRAM/DIEP flaps, with neurotization

Procedure: Neurotization - Autologous Reconstruction with DIEP/TRAM

Autologous with TRAM/DIEP flaps, without neurotization

NO INTERVENTION

Autologous with TRAM/DIEP flaps, without neurotization

Interventions

Neurotization - Autologous Reconstruction with DIEP/TRAM PROCEDURE

* Transverse Rectus Abdominis Muscle/Deep Inferior Epigastric Artery Flap Harvest - Prior to elevation of flaps in the suprafascial plane from using loupe magnification to identify medial and lateral row of perforators bilaterally, sensory nerves T10-12 are identified and dissected into the muscle bilaterally to prepare for nerve coaptation, nerves are divided at the level of the fascia where they are pure sensory nerves. * Chest Intercostal Nerve Harvest - During standard of care chest vessel dissection, intercostal nerves T3-4 are identified. After completion of vein coupling it will be determined whether neurotization can be performed or if autograft. Primary nerve coaptation will be performed if there is adequate length for direct end to end apposition. * Coaptation of nerve or nerve graft endings will be performed using 9-0 nylon suture in an interrupted fashion.

Autologous with TRAM/DIEP flaps, with neurotization

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: The study population will consist of subjects with breast cancer who are scheduled for breast reconstruction and meet all inclusion/exclusion requirements.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing to provide informed consent
• The patient is ≥ 18 years
• Patients presenting to UW Health who have had or will have unilateral or bilateral mastectomy (therapeutic or prophylactic) and are planning to undergo autologous reconstruction with TRAM/DIEP will be included

You may not qualify if:

• Patient is non-English speaking
• Patient is known or believed to be pregnant
• Patient is a minor (individuals \<18 years old)
• Patient is a prisoner
• Individuals unable to give consent due to another condition such as impaired decision-making capacity
• Autologous reconstruction where the flap is buried (e.g. there is no autologous skin exposed for sensation testing)
• Patient is a male
• Any patient with: diabetic neuropathy, thyroid disorders, collagen vascular disease, alcoholism, pernicious anemia, or any other severe underlying peripheral neuropathy
• Women with recurrent breast cancer
• Women who have undergone previous breast reconstructive procedures
• Not suitable for study participation due to other reasons at the discretion of the investigators
• Patient is currently lactating
• History of radiation therapy
• Patient undergoing a latissimus dorsi flap for reconstruction
• Patient undergoing alloplastic reconstruction

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Officials

• Brett F Michelotti, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2022
• First Posted: January 25, 2022
• Study Start: March 1, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: January 9, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share