Nipple sensation after conventional, endoscopic, or robotic nipple-sparing mastectomy
NIPSENSE - A Comparative Study of Nipple and Skin Sensation Preservation After Nipple-Sparing Mastectomy With Conventional, Endoscopic, and Robotic Techniques
We will test whether conventional, endoscopic, or robotic nipple-sparing mastectomy helps women keep more nipple sensation after mastectomy with immediate implant reconstruction.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Candiolo Cancer Institute - IRCCS Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Torino) |
| Trial ID | NCT07062458 on ClinicalTrials.gov |
What this trial studies
This is a prospective, single-center comparison of three surgical approaches to nipple-sparing mastectomy: conventional, endoscopic, and robotic techniques. Ninety women (30 per group) undergoing direct-to-implant reconstruction will be enrolled and followed. Nipple and skin sensation will be measured with a Semmes-Weinstein esthesiometer before surgery and at 1, 3, and 6 months after surgery, alongside validated patient-reported body image and quality-of-life questionnaires and tracking of surgical complications. Surgical tissue will be analyzed to explore whether preserved nerve structures correlate with measured sensation.
Who should consider this trial
Good fit: Women aged 18 or older with early-stage breast cancer or a high genetic risk who are candidates for nipple-sparing mastectomy with immediate implant reconstruction and who can attend scheduled follow-up visits are ideal candidates.
Not a fit: Patients with prior breast surgery or chest radiation, uncontrolled diabetes or neuropathies, or those with nipple tumor involvement requiring conversion to a different surgery are unlikely to benefit from this protocol or be eligible.
Why it matters
Potential benefit: If successful, the results could help surgeons choose the approach that best preserves nipple sensation and improves body image and quality of life after mastectomy.
How similar studies have performed: Small series and single-center reports indicate NSM can preserve some nipple sensation and early reports of endoscopic and robotic approaches are promising, but direct head-to-head comparisons are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Torino
- Candiolo Cancer Institute FPO-IRCCS — Torino, Italy (Recruiting)
Study contacts
- Principal investigator: Giada Pozzi, MD — Candiolo Cancer Institute FPO-IRCCS
- Study coordinator: Giada Pozzi, MD
- Email: giada.pozzi@ircc.it
- Phone: +39 011 9933017
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.