Sexual Well-being of Women Undergoing Mastectomy and Reconstruction

Recruiting now · Not applicable

Conditions studied: Mastectomy and Breast Reconstruction, Sexual Wellness

In brief

The study plans to collect data from patients on sexual well-being after mastectomy and immediate reconstruction by surveys. This data can support preoperative patient counselling and the prevention and care of adverse effects of cancer treatments. Specific subpopulations of mastectomy women showing severe sexual impairment can be outlined; they may benefit from lifestyle changes and intervention strategies (intravaginal use of diazepam, local hyaluronic acid, intravaginal use of spermidine, pelvic floor gymnastic and physiotherapy). Our goal is to improve quality of life of breast cancer patients.

Key facts

Study ID

NCT07234461

Run by

European Institute of Oncology

People needed

200

Starts

2026-01-21

Expected to finish

2026-10-01

Last updated by the study team

2026-02-04

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Patients undergoing mastectomy for primary breast cancer;
• High-risk healthy patients undergoing risk reducing mastectomies;
• Unilateral and/or bilateral mastectomies;
• If unilateral mastectomy, both patients requiring or not contralateral mammaplasty of the healthy breast;
• All reconstructive procedures included (autologous and heterologous reconstructions).

You may not qualify if…

• Patients undergoing breast conservation;
• Patients who previously underwent breast cancer treatment, requiring further surgery for local relapse or secondary breast cancers;
• Delayed post-mastectomy reconstructions;
• Patients not available for e-correspondence.

Where it is running

• European Institute of Oncology — Milan, Italy, Italy (enrolling)
• Istituto Tumori Giovanni Paolo II — Bari, Italy, Italy
• Policlinico Sant'Orsola-Malpighi — Bologna, Italy, Italy
• Ospedale Bufalini di Cesena — Cesena, Italy, Italy
• Presidio Ospedaliero GB Morgagni-Pierantoni — Forlì, Italy, Italy
• Ospedale Mater Olbia — Olbia, Italy, Italy
• Azienda Ospedale Università di Padova — Padova, Italy, Italy
• Policlinico Paolo Giaccone — Palermo, Italy, Italy
• Policlinico San Matteo — Pavia, Italy, Italy
• Azienda Ospedaliero Universitaria Pisana — Pisa, Italy, Italy
• Campus Biomedico — Roma, Italy, Italy
• Istituto Tumori Regina Elena — Roma, Italy, Italy
• Policlinico Gemelli — Roma, Italy, Italy
• A.O.U. Città della salute e della scienza di Torino — Torino, Italy, Italy
• Azienda Ospedaliera di Treviso — Treviso, Italy, Italy
• Ospedale di Cattinara — Trieste, Italy, Italy
• Ospedale Universitario di Udine — Udine, Italy, Italy
• Azienda Ospedaliero Universitaria Consorziale Policlinico — Bari, Italy, Italy
• Breast Unit Settelaghi — Varese, Italy, Italy

Full record on ClinicalTrials.gov

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