RECRUITING

A Bionic Breast Project Using Neuroprosthesis to Reduce Chronic Pain After Mastectomy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This trial seeks to establish whether or not touch sensation can be restored to the breast via neural stimulation. Data will also be obtained to inform future feasibility (including safety), efficacy, and acceptability trials.

Official Title

Bionic Breast Project: A Neuroprosthesis to Restore Touch Sensation and Reduce Chronic Pain After Mastectomy

Quick Facts

Study Start:2025-02-18

Study Completion:2033-06-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06382272

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 18 years of age or older * Scheduled for bilateral mastectomy with two-stage (tissue expander) reconstruction at UCM * Bilateral mastectomy for unilateral in situ or T1 (\<2 cm), N0 (no lymph node involvement) breast cancer or breast cancer risk reduction due to known elevated breast cancer risk. (Note - 19-34% of women choosing mastectomy for small unilateral breast cancer elect bilateral mastectomy.)40 We will enroll from this cohort. * Agrees to have breast tissue expander removed within 12-20 weeks of implantation. * Has access to a cell phone and willing to provide the research interviewer with the cell phone number * Agrees to receive text messages from the study * Able to speak and understand English or Spanish * Able to participate in the informed consent process	* Requires breast radiation * Single stage mastectomy and reconstruction procedure * Clinical evidence of bilateral breast cancer * Clinical evidence of lymph node involvement * Prior history of mastectomy or other major breast surgery * Prior history of radiation to the chest area (e.g., mantle radiation for Hodgkin's disease) * Prior history of injury (e.g., trauma, surgery, burn) that the participant perceives to have had an effect on the sensation of the breast * Pregnant or intending to become pregnant during the study period * Pacemaker, defibrillator or other implanted electrical stimulation device that may be affected by the implanted electrodes * Complex regional pain syndrome or other pain syndromes or a history of a neurologic condition like multiple sclerosis, degenerative neurological disease, cognitive impairment or dementia * Uncontrolled diabetes * History of poor wound healing or chronic skin ulcerations * History of uncontrolled infection or active infection at time of consent * Expectation that MRI will be required while the devices are implanted * Inability or unwillingness to follow verbal instructions and comply with study procedures * Untreated or poorly managed physical or mental health condition that may pose additional risk according to clinical judgment of the patient's breast surgeon or surgeons * Unwillingness to undergo psychological evaluation to determine study eligibility, if requested or required by surgeons or investigators

Inclusion Criteria

Exclusion Criteria

* 18 years of age or older
* Scheduled for bilateral mastectomy with two-stage (tissue expander) reconstruction at UCM
* Bilateral mastectomy for unilateral in situ or T1 (\<2 cm), N0 (no lymph node involvement) breast cancer or breast cancer risk reduction due to known elevated breast cancer risk. (Note - 19-34% of women choosing mastectomy for small unilateral breast cancer elect bilateral mastectomy.)40 We will enroll from this cohort.
* Agrees to have breast tissue expander removed within 12-20 weeks of implantation.
* Has access to a cell phone and willing to provide the research interviewer with the cell phone number
* Agrees to receive text messages from the study
* Able to speak and understand English or Spanish
* Able to participate in the informed consent process

* Requires breast radiation
* Single stage mastectomy and reconstruction procedure
* Clinical evidence of bilateral breast cancer
* Clinical evidence of lymph node involvement
* Prior history of mastectomy or other major breast surgery
* Prior history of radiation to the chest area (e.g., mantle radiation for Hodgkin's disease)
* Prior history of injury (e.g., trauma, surgery, burn) that the participant perceives to have had an effect on the sensation of the breast
* Pregnant or intending to become pregnant during the study period
* Pacemaker, defibrillator or other implanted electrical stimulation device that may be affected by the implanted electrodes
* Complex regional pain syndrome or other pain syndromes or a history of a neurologic condition like multiple sclerosis, degenerative neurological disease, cognitive impairment or dementia
* Uncontrolled diabetes
* History of poor wound healing or chronic skin ulcerations
* History of uncontrolled infection or active infection at time of consent
* Expectation that MRI will be required while the devices are implanted
* Inability or unwillingness to follow verbal instructions and comply with study procedures
* Untreated or poorly managed physical or mental health condition that may pose additional risk according to clinical judgment of the patient's breast surgeon or surgeons
* Unwillingness to undergo psychological evaluation to determine study eligibility, if requested or required by surgeons or investigators

Contacts and Locations

Study Contact

Clinical Trials Intake

CONTACT

18557028222

cancerclinicaltrials@bsd.uchicago.edu

Principal Investigator

Stacy Lindau

PRINCIPAL_INVESTIGATOR

University of Chicago

Study Locations (Sites)

University of Chicago Medicine Comprehensive Cancer Center

Chicago, Illinois, 60637

United States

Collaborators and Investigators

Sponsor: University of Chicago

Stacy Lindau, PRINCIPAL_INVESTIGATOR, University of Chicago

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-18

Study Completion Date2033-06-15

Study Record Updates

Study Start Date2025-02-18

Study Completion Date2033-06-15

Terms related to this study

Additional Relevant MeSH Terms

Mastectomy
Breast
Chronic Pain