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NCT Number: NCT07062458

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

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)

Recruiting

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Key information

Conditions

Sensation Disorder Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Candiolo Cancer Institute FPO-IRCCS

Torino, 10060, Italy

Location status: Recruiting

Location contact

Candiolo Cancer Institute FPO-IRCCS

CONTACT

[email protected]

+39 0119933111

About this study

The NIPSENSE study is a prospective, single-center study comparing how well nipple sensation is preserved after three types of nipple-sparing mastectomy (NSM): Conventional NSM (C-NSM), Endoscopic NSM (E-NSM), and Robotic NSM (R-NSM). The goal is to better understand the sensory and quality-of-life outcomes associated with each technique.

A total of 90 female participants (30 in each group) will be recruited. All will undergo NSM with direct-to-implant reconstruction. Participants will be assessed for nipple and skin sensation before surgery, and again at 1, 3, and 6 months after surgery, using a standard medical tool called the Semmes-Weinstein esthesiometer.

The study will also evaluate:

Surgical complications (e.g., infection, bleeding, skin necrosis)

Patient-reported outcomes using validated tools like the Hopwood Body Image Scale and EORTC questionnaires

Tissue analysis to explore whether preserved nerve structures are related to the level of sensation after surgery

This study will provide important data about how surgical methods impact physical and emotional outcomes for people undergoing mastectomy. The findings may help improve patient care and inform future decisions about surgical approaches to breast cancer treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

Nipple Sensation Assessment

Diagnostic Test

the measurement of nipple sensation preservation, will be conducted using the Semmes-Weinstein esthesiometer. The clinician will use the device to touch the nipple and the surrounding quadrants of the skin, applying filaments of increasing calibers (0.07gr, 0.4gr, 2.0gr, 4.0gr, 300gr), and the lightest caliber perceived by the patient will be recorded. This assessment will be conducted at four different times:

  • Before surgery, to assess baseline sensation.
  • 1 month after surgery.
  • 3 months after surgery.
  • 6 months after surgery.

Primary outcomes

  1. measurement of nipple sensation preservation

    Time frame: This assessment will be conducted at four different times: • Before surgery, to assess baseline sensation. • 1 month after surgery. • 3 months after surgery. • 6 months after surgery.

    The primary objective, the measurement of nipple sensation preservation, will be conducted using the Semmes-Weinstein esthesiometer. The clinician will use the device to touch the nipple and the surrounding quadrants of the skin, applying filaments of increasing calibers (0.07gr, 0.4gr, 2.0gr, 4.0gr, 300gr), and the lightest caliber perceived by the patient will be recorded.

Secondary outcomes

  1. surgical outcomes

    Time frame: from enrollment to 3 months

    nipple-areola complex necrosis, skin flaps necrosis, infection, bleeding, seroma, wound dehiscence,

  2. anatomopathological findings

    Time frame: 30-60 days post-surgery

    the presence or absence of sensory cutaneous receptors in the subcutaneous layer of the specimen and their possible correlation to the degree of cutaneous sensation

  3. PROMs

    Time frame: From enrollment to 6 monts postoperatively

    Questionnaires will be administered to the patients to assess patient-reported outcomes: Hopwood Body Image Scale (score 0 to 30, higher scores meaning a worst outcome), and EORTC - European Organisation for Research and Treatment of Cancer, BR-23 questionnaire (no total score, each question compared individually between groups)

Study contacts

Contact information is provided by the study sponsor or research team.

Giada Pozzi, MD

CONTACT

[email protected]

+39 011 9933017

Sponsors and collaborators

Lead sponsor

Candiolo Cancer Institute - IRCCS

Other

Registry information

Official study title

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

Acronym: NIPSENSE

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 14, 2025
Registry last updated
Jul 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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