Effect of Neurotization on QoL and Sensory Restoration

N/AWithdrawnNCT05206565

University of Wisconsin, Madison

Overview

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.

In 2019, nearly one third of cancers diagnosed in the United States were breast cancers. Per the Plastic Surgery procedural statistics from the American Society of Plastic Surgery database, that same year approximately 107,000 patients decided to pursue either alloplastic (ex. Tissue expander or implant based) or autologous (ex. Transverse Rectus Abdominis Muscle (TRAM), Deep Inferior Epigastric Perforator (DIEP) flaps) breast reconstruction, an increase of 5% from 2018. Over the past few decades, as surgical techniques have continued to improve, postoperative concerns have transitioned towards the patient's aesthetic outcome and satisfaction. While the appropriate size, shape, and symmetry of the breast are crucial goals to achieve, another issue facing patients is that without sensation the reconstructed breast does not feel like their own. In most patients there is diminished, if not absent, sensation in the reconstructed breast. The lack of sensation can not only put patients at risk of injury, but also can impact their lives sexually and socially. The goal of this randomized, double-blinded study is to prospectively evaluate the impact of neurotization on breast-specific quality of life in patients who have undergone autologous reconstruction. Secondary objectives are to also look at additional health-related quality of life outcomes using validated surveys (e.g. PROMIS and NIH Toolbox). These NIH-funded surveys will be analyzed to assess factors important to surgical impact on physical function, mental function, social function, pain, and sexual function. Finally, investigators will objectively measure differences in sensation. Investigators hypothesize that breast neurotization will improve both breast- and health-related patient quality of life outcomes as well as objective sensation. The duration of this study is expected to be approximately 48 months in order to recruit an appropriate number of patients and have adequate postoperative follow up.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Conditions

Breast Reconstruction Neurotization

Interventions

Neurotization - Autologous Reconstruction with DIEP/TRAMPROCEDURE

* 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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Outcomes

Primary Outcomes

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).

Time frame: approximately 12 months after reconstruction

Secondary Outcomes

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

Time frame: 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

The Patient-Reported Outcome Measurement Information System (PROMIS) Ability to Participate in Social Roles and Activities SF8a is a self-administered instrument to assess perceived ability to perform one's usual social roles and activities. Items are worded negatively in terms of perceived limitations, but responses are reverse-coded so that higher scores represent fewer limitations (better abilities). The item bank does not use a time frame (e.g. over the past seven days) when assessing ability to participate in social roles and activities.

Data from ClinicalTrials.gov

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