Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
Healthy Volunteers
NCT07234461

Sexual Well-being of Women Undergoing Mastectomy and Reconstruction

Led by European Institute of Oncology · Updated on 2026-02-04

200

Participants Needed

19

Research Sites

36 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Sexual Well-being of Women Undergoing Mastectomy and Reconstruction

Who Can Participate

Age: 18Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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)
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 19 locations

1

Azienda Ospedaliero Universitaria Consorziale Policlinico

Bari, Italy, Italy, 70124

Not Yet Recruiting

2

Istituto Tumori Giovanni Paolo II

Bari, Italy, Italy, 70124

Not Yet Recruiting

3

Policlinico Sant'Orsola-Malpighi

Bologna, Italy, Italy, 40138

Not Yet Recruiting

4

Ospedale Bufalini di Cesena

Cesena, Italy, Italy, 47521

Not Yet Recruiting

5

Presidio Ospedaliero GB Morgagni-Pierantoni

Forlì, Italy, Italy, 47121

Not Yet Recruiting

6

European Institute of Oncology

Milan, Italy, Italy, 20141

Actively Recruiting

7

Ospedale Mater Olbia

Olbia, Italy, Italy, 07026

Not Yet Recruiting

8

Azienda Ospedale Università di Padova

Padova, Italy, Italy, 35128

Not Yet Recruiting

9

Policlinico Paolo Giaccone

Palermo, Italy, Italy, 90127

Not Yet Recruiting

10

Policlinico San Matteo

Pavia, Italy, Italy, 27100

Not Yet Recruiting

11

Azienda Ospedaliero Universitaria Pisana

Pisa, Italy, Italy, 56100

Not Yet Recruiting

12

Campus Biomedico

Roma, Italy, Italy, 00128

Not Yet Recruiting

13

Istituto Tumori Regina Elena

Roma, Italy, Italy, 00144

Not Yet Recruiting

14

Policlinico Gemelli

Roma, Italy, Italy, 00168

Not Yet Recruiting

15

A.O.U. Città della salute e della scienza di Torino

Torino, Italy, Italy, 10126

Not Yet Recruiting

16

Azienda Ospedaliera di Treviso

Treviso, Italy, Italy, 31100

Not Yet Recruiting

17

Ospedale di Cattinara

Trieste, Italy, Italy, 34149

Not Yet Recruiting

18

Ospedale Universitario di Udine

Udine, Italy, Italy, 33100

Not Yet Recruiting

19

Breast Unit Settelaghi

Varese, Italy, Italy, 21100

Not Yet Recruiting

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Research Team

F

Francesca De Lorenzi, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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