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Nipple Delay Prior to Nipple Sparing Mastectomy: A Pilot RCT

NCT02526719 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2015-11-02

No results posted yet for this study

Summary

The goal of nipple-sparing mastectomy (NSM) with immediate breast reconstruction is to reconstruct a breast mound with preservation a patient's natural skin envelope. Preservation of the nipple and areola complex during mastectomy and breast reconstruction is associated with improved quality of life and a better cosmetic result. However, this surgical technique relies on tenuous blood supply to maintain the nipple and areola. Therefore a certain proportion of women will actually lose their preserved nipple-areolar complex due to vascular insufficiency. Furthermore, some women may find out after a nipple-sparing mastectomy that cancer had invaded the nipple-areolar complex, and would require another operation to completely remove the cancer. Despite these devastating complications, there have been no controlled studies to investigate mechanisms to reduce the chance of their occurrence.

Our research study will use a pre-operative minor procedure to enhance blood flow to the nipple-areola complex prior to standard nipple sparing mastectomy among eligible women undergoing mastectomy for breast cancer or risk reduction. A secondary objective is to test how many women actually have active cancer in their nipple at the time of this minor surgical procedure, prior to standard NSM. The investigators hypothesize that our innovative and novel nipple-delay procedure will reduce the risk of loss of the nipple due to vascular insufficiency and may be of benefit to identify the small proportion of women with nipple-areola complex involvement, in order to optimize the ultimate cancer ablation.

For this study the investigators propose to undertake a Pilot RCT as the first step in the evaluation of a delay procedure prior to NSM, and the results will be used to determine the feasibility and inform the optimal design for a definitive RCT. This study question has the potential to set a new standard of care in the management of women seeking NSM for the management of their breast cancer.

Conditions

Interventions

PROCEDURE

Nipple Delay surgery

The nipple delay surgery will be performed by the plastic surgeon as an outpatient procedure in the minor procedure room under local anaesthetic 7 - 21 days prior definitive NSM with IBR. The skin flap will be elevated in the plane of the prophylactic mastectomy beneath the NAC. A nipple core biopsy and a 1cm thick biopsy of immediately subareolar ductal tissue will be submitted for permanent section pathology. This approach is consistent with the previous case series of nipple delay for NSM and has been approved by the multi-disciplinary breast cancer team at our institutions. Patients that have a positive nipple core or sub-areolar biopsy will have the NAC removed at time of definitive mastectomy.

Sponsors & Collaborators

  • University Health Network, Toronto

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2015-09-30
Completion
2016-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02526719 on ClinicalTrials.gov