Nerve Reconnection Procedure (Neurotization) for the Improvement of Sensation and Quality of Life after Breast Reconstruction Surgery
This clinical trial studies the impact of a nerve reconnection procedure (neurotization) on breast cancer patients' quality of life and sensation. Normally during breast reconstruction, neurotization is not performed and patients may experience loss or decrease in sensation in their reconstructed breast for variable amounts of time after surgery which may impact their lives. Performing neurotization may have an impact on patients' quality of life after their surgery or improve the sensation they develop in their reconstructed breast.
Inclusion Criteria
- Willing to provide informed consent
- The patient is >= 18 years
- Patients presenting to University of Wisconsin (UW) Health who have had or will have unilateral or bilateral mastectomy (therapeutic or prophylactic) and are planning to undergo autologous reconstruction with DIEP will be included
- Patients presenting to UW Health who have had or will have unilateral or bilateral mastectomy (therapeutic or prophylactic) and are planning to undergo alloplastic breast reconstruction (e.g., tissue expanders or direct to implant) 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
- Current enrollment in another research study
- Not suitable for study participation due to other reasons at the discretion of the investigators
- Patient is currently lactating
- History of radiation therapy
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05206565.
PRIMARY OBJECTIVES:
I. To compare patient-reported, breast-specific, health-related quality of life (QoL) in breast cancer patients who have undergone autologous reconstruction with DIEP (Deep Inferior Epigastric Perforator) flaps with and without neurotization, at 12 months after the reconstruction.
II. To compare patient-reported, breast-specific, health-related QoL in breast cancer patients who have undergone alloplastic breast reconstruction (e.g., tissue expanders or direct to implant) with and without neurotization, at 12 months after the reconstruction.
SECONDARY OBJECTIVES:
I. To compare patient-reported, breast-specific, health-related QoL in breast cancer patients who have undergone autologous reconstruction with DIEP flaps with and without neurotization, at 1-3 weeks, 6 weeks, 3 months, 6 months, 12 months, and 18 months after the reconstruction.
II. To compare patient-reported, breast-specific, health-related QoL in breast cancer patients who have undergone alloplastic breast reconstruction (e.g., tissue expanders or direct to implant) with and without neurotization, at 1-3 weeks, 6 weeks, 3 months, 6 months, 12 months, and 18 months after the reconstruction.
III. To compare additional patient-reported, health-related QoL indices (social functioning, pain interference, and positive and negative psychosocial outcomes of illness) in breast cancer patients who have undergone autologous reconstruction with DIEP flaps with and without neurotization, at 1-3 weeks, 6 weeks, 3 months, 6 months, 12 months, and 18 months after the reconstruction.
IV. To compare additional patient-reported, health-related QoL indices (social functioning, pain interference, and positive and negative psychosocial outcomes of illness) in breast cancer patients who have undergone alloplastic breast reconstruction (e.g., tissue expanders or direct to implant) with and without neurotization, at 1-3 weeks, 6 weeks, 3 months, 6 months, 12 months, and 18 months after the reconstruction.
V. To compare change in patient-reported, breast-specific, health-related QoL in breast cancer patients who have undergone autologous reconstruction with DIEP flaps with and without neurotization, from baseline to 1-3 weeks, 6 weeks, 3 months, 6 months, 12 months, and 18 months after the reconstruction.
VI. To compare change in patient-reported, breast-specific, health-related QoL in breast cancer patients who have undergone alloplastic breast reconstruction (e.g., tissue expanders or direct to implant) with and without neurotization, from baseline to 1-3 weeks, 6 weeks, 3 months, 6 months, 12 months, and 18 months after the reconstruction.
VII. To compare change in additional patient-reported, health-related QoL indices (social functioning, pain interference, and positive and negative psychosocial outcomes of illness) in breast cancer patients who have undergone autologous reconstruction with DIEP flaps with and without neurotization, from baseline to 1-3 weeks, 6 weeks, 3 months, 6 months, 12 months, and 18 months after the reconstruction.
VIII. To compare change in additional patient-reported, health-related QoL indices (social functioning, pain interference, and positive and negative psychosocial outcomes of illness) in breast cancer patients who have undergone alloplastic breast reconstruction (e.g., tissue expanders or direct to implant) with and without neurotization, from baseline to 1-3 weeks, 6 weeks, 3 months, 6 months, 12 months, and 18 months after the reconstruction.
IX. To compare breast sensation in breast cancer patients who have undergone autologous reconstruction with DIEP flaps with and without neurotization, at 1-3 weeks, 6 weeks, 6 months, 12 months, and 18 months after the reconstruction.
X. To compare breast sensation in breast cancer patients who have undergone alloplastic breast reconstruction (e.g., tissue expanders or direct to implant) with and without neurotization, at 1-3 weeks, 6 weeks, 6 months, 12 months, and 18 months after the reconstruction.
XI. To compare change in breast sensation in breast cancer patients who have undergone autologous reconstruction with DIEP flaps with and without neurotization, from baseline to 1-3 weeks, 6 weeks, 3 months, 6 months, 12 months, and 18 months after the reconstruction.
XII. To compare change in breast sensation in breast cancer patients who have undergone alloplastic breast reconstruction (e.g., tissue expanders or direct to implant) with and without neurotization, from baseline to 1-3 weeks, 6 weeks, 3 months, 6 months, 12 months, and 18 months after the reconstruction.
OUTLINE: Patients are randomized into 1 of 2 arms.
ARM I: Patients undergo neurotization during standard of care reconstructive surgery.
ARM II: Patients undergo standard of care reconstructive surgery.
After completion of the study intervention, patients are followed up at 1-3 weeks, at 6 weeks, at 3, 6, 12, and 18 months, and at 2 years.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationUniversity of Wisconsin Carbone Cancer Center - University Hospital
Principal InvestigatorBrett F. Michelotti
- Primary IDUW21028
- Secondary IDsNCI-2022-01596, 2021-0290
- ClinicalTrials.gov IDNCT05206565