A Comparative Study of Nipple Sensation Preservation After Nipple-Sparing Mastectomy With Conventional, Endoscopic, Robotic Techniques

Recruiting now

Conditions studied: Sensation Disorder

In brief

The goal of this comparative study is to learn how different surgical methods affect nipple and skin sensation after nipple-sparing mastectomy (NSM). The study will compare three types of NSM: conventional, endoscopic, and robotic. The main question it aims to answer is: How much nipple sensation do participants keep after each type of surgery? Researchers will also look at surgery-related complications, patient-reported outcomes like body image and quality of life, and tissue analysis to see if there is a link between nerve structures and sensation. Participants will: Have NSM using one of the three surgical approaches Receive breast reconstruction with an implant during the same surgery Complete nipple sensation tests before and at 1, 3, and 6 months after surgery Answer surveys about their quality of life and body image Provide surgical tissue for analysis (as part of the planned procedure)

Key facts

Study ID

NCT07062458

Run by

Candiolo Cancer Institute - IRCCS

People needed

90

Starts

2025-06-01

Expected to finish

2027-12-01

Last updated by the study team

2025-07-14

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Female patients aged ≥18 years.
• Diagnosed with early-stage breast cancer or deemed at high risk for breast cancer (eg. BRCA1-2 mutations).
• Candidates for Nipple-Sparing Mastectomy (NSM).
• Able to provide informed consent.
• No contraindications for surgery based on physical examination and preoperative assessment.
• Signed the consent forms and willing to participate in all scheduled follow-up assessments.

You may not qualify if…

• Previous breast surgery.
• History of radiation therapy to the chest/breast area.
• Active or non-controlled diabetes mellitus.
• Neuropathies causing potentially altered skin sensation.
• Nipple involvement by cancer, clinical or reported intra-operatively via frozen section analysis (the procedure will be converted to SSM).

Where it is running

• Candiolo Cancer Institute FPO-IRCCS — Torino, Italy (enrolling)

Full record on ClinicalTrials.gov

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