Sensation After Nipple Sparing Mastectomy and Breast Reconstruction With or Without Neurotized Free Tissue Transfer

NCT03135392 | Withdrawn DMC

• 1 other identifier: CASE2117
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Tissue Expander/Implant Reconstruction: The purpose of this study is to determine how and when nerve sensation to the breast skin returns after mastectomy. Autologous Tissue Reconstruction: The purpose of this study is to determine whether the tissue being used to reconstruct your breast can provide sensation by using your own nerves. Typically all sensation is lost immediately after this type of surgery and returns to varying degrees. We are hoping to demonstrate that by connecting the two nerves (one from abdomen and one from the chest wall) together, we can attain meaningful sensation in the transferred tissues thereby improving your quality of life following surgery.

Conditions

Mastectomy; Breast Reconstruction

Keywords

Breast Cancer; sensation recovery; Neurotization

Outcome Measures

Primary Outcomes (1)

• Composite measure of sensation

  Differences of at least 20% comparing control to experimental breasts would be clinically meaningful. Composite measure will be calculated by combining the follow binomial factors: detection of temperature difference (feeling hot and cold), detection of sharp versus dull pressure, detection of vibration, discerning point pressure

  Up to 24 months after surgery

Secondary Outcomes (1)

• Quality of Life as measured by a 19-question survey regarding sensation and appearance of breast.

  Up to 24 months after surgery

Study Arms (3)

Breast Reconstruction with Artificial Implant

ACTIVE COMPARATOR

Participants undergoing unilateral reconstruction: patient will serve as internal control with contralateral breast and reconstructed breast will be compared to all other reconstructed breasts. Participants undergoing bilateral reconstruction: reconstructed breasts will be compared to all other reconstructed breasts

Procedure: Breast Reconstruction with Artificial Implant

Autologous Breast Reconstruction without Neurotization

ACTIVE COMPARATOR

Participants undergoing autologous tissue (her own tissue from other areas of the body) reconstruction which do not have their nerves reconstructed during surgery

Procedure: Autologous Breast Reconstruction

Autologous Breast Reconstruction with Neurotization

EXPERIMENTAL

Participants undergoing autologous tissue (her own tissue from other areas of the body) reconstruction which have a nerve connected (neurotized) during surgery.

Procedure: Autologous Breast Reconstruction; Procedure: Neurotization

Interventions

Breast Reconstruction with Artificial Implant PROCEDURE

Patients undergo unilateral or bilateral reconstruction of breasts after nipple sparing mastectomy. Breasts are reconstructed with artificial implants

Breast Reconstruction with Artificial Implant

Autologous Breast Reconstruction PROCEDURE

Patients undergo unilateral or bilateral reconstruction of breasts after nipple sparing mastectomy. Breasts are reconstructed with the patient's own tissue

Autologous Breast Reconstruction with Neurotization; Autologous Breast Reconstruction without Neurotization

Neurotization PROCEDURE

Nerve will be reconstructed during autologous breast tissue reconstruction

Also known as: Nerve Reconstruction

Autologous Breast Reconstruction with Neurotization

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing unilateral or bilateral skin sparing mastectomy for breast cancer
• Patient must have one of the following reconstructions in planned:
• Immediate tissue expander placement
• Immediate implant placement
• Immediate autologous breast reconstruction
• All patients participating in the study must be willing to be consented for enrollment at the pre-operative visit.

You may not qualify if:

• Pre-operative radiation therapy
• Any pre-excising
• Patients with absent or prior damaged nipple areola-complex (NAC) on the "non-surgical breast"

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

Cleveland Clinic, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Mammaplasty; Prostheses and Implants; Nerve Transfer

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cosmetic Techniques; Therapeutics; Plastic Surgery Procedures; Surgical Procedures, Operative; Equipment and Supplies; Neurosurgical Procedures

Study Officials

• Andrea Moreira, MD

  Cleveland Clinic, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants who are having implant reconstruction will act as controls for all other breast reconstructions. If the participant is having autologous tissue reconstruction, she will be randomly put into one of the study groups. Neither the study doctor nor the participant can choose the treatment. Assignment is done randomly, like the flip of a coin. If the participant is having only one breast reconstructed, she will be randomly assigned to either receive the nerve reconstruction or not. If the participant is having both of her breasts reconstructed, one side will receive the nerve reconstruction and one will not. The participant will not know which group you have been assigned to until the completion of the study or if voluntarily withdraw from the study
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective cohort study

Study Record Dates

• First Submitted: April 27, 2017
• First Posted: May 1, 2017
• Study Start: October 1, 2018
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: November 14, 2018

Record last verified: 2018-11

Locations

US (1)