Mastectomy and Breast ReconstructionNCT07234461
Sexual Well-being of Women Undergoing Mastectomy and Reconstruction
A study testing Survey using a questionnaire. in people with Mastectomy and Breast Reconstruction and Sexual Wellness, run by European Institute of Oncology at 19 sites in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mastectomy and Breast Reconstruction, Sexual Wellness
- What is being tested?
- Survey using a questionnaire.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 19 sitesItaly
- Study dates
- 21 Jan 2026to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
19 sites in 1 country. Contact the study team or a site near you to ask about taking part.
19 sites in 1 country
Italy19 sites, 19 recruiting
- Not yet recruiting
Azienda Ospedaliero Universitaria Consorziale Policlinico
Bari, Italy, 70124
Angela Gurrado, MD, +39 080 919 8749, urp.policlinico.bari@pec.rupar.puglia.it
Angela Gurrado, MD
- Not yet recruiting
Istituto Tumori Giovanni Paolo II
Bari, Italy, 70124
Daniela Anna Cutrignelli, MD, +39 0805555917, d.cutrignelli@oncologico.bari.it
Daniela Anna Cutrignelli, MD
- Not yet recruiting
Policlinico Sant'Orsola-Malpighi
Bologna, Italy, 40138
Chiara Gelati, MD, +39 051 2143614, angela.sandoni@aosp.bo.it
Chiara Gelati, MD
- Not yet recruiting
Ospedale Bufalini di Cesena
Cesena, Italy, 47521
Rossella Sgarzani, MD, +39 0547 352111, rossella.sgarzani2@unibo.it
Rossella Sgarzani, MD
- Not yet recruiting
Presidio Ospedaliero GB Morgagni-Pierantoni
Forlì, Italy, 47121
Annalisa Curcio, MD, +39 0543731676, curcioannalisa@hotmail.it
Annalisa Curcio, MD
- Recruiting
European Institute of Oncology
Milan, Italy, 20141
Francesca De Lorenzi, MD, +39 0257489.394, francesca.delorenzi@ieo.it
Francesca De Lorenzi, MD
- Not yet recruiting
Ospedale Mater Olbia
Olbia, Italy, 07026
Sonia Bove, MD, +39 0789 18999, sonia.bove@materolbia.com
Sonia Bove, MD
- Not yet recruiting
Azienda Ospedale Università di Padova
Padova, Italy, 35128
Laura Pandis, MD, +39 0498212768, chir.plastica@aopd.veneto.it
Laura Pandis, MD
- Not yet recruiting
Policlinico Paolo Giaccone
Palermo, Italy, 90127
Adriana Cordova, MD, +39 091 655 34 00, adriana.cordova@policlinico.pa.it
Adriana Cordova, MD
- Not yet recruiting
Policlinico San Matteo
Pavia, Italy, 27100
Adele Sgarella, MD, +39 0382502288, a.sgarella@smatteo.pv.it
Adele Sgarella, MD
- Not yet recruiting
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy, 56100
Manuela Roncella, MD, +39 050992729, s.palmiero@ao-pisa.toscana.it
Manuela Roncella, MD
- Not yet recruiting
Campus Biomedico
Roma, Italy, 00128
Barbara Cagli, MD, +39 06 9762 0968, b.cagli@unicampus.it
Barbara Cagli, MD
- Not yet recruiting
Istituto Tumori Regina Elena
Roma, Italy, 00144
Lucia Mangialardi, MD, +39 351 319 1190, segreteria.drmangialardi@gmail.com
Lucia Mangialardi, MD
- Not yet recruiting
Policlinico Gemelli
Roma, Italy, 00168
Marzia Salgarello, MD, +39 06 3015.4667, marzia.salgarello@policlinicogemelli.it
Marzia Salgarello, MD
- Not yet recruiting
A.O.U. Città della salute e della scienza di Torino
Torino, Italy, 10126
Maria Alessandra Bocchiotti, MD, +39 0116336991, mariaalessandra.bocchiotti@unito.it
Maria Alessandra Bocchiotti, MD
- Not yet recruiting
Azienda Ospedaliera di Treviso
Treviso, Italy, 31100
Elisa Antoniazzi, MD, +39 0422 322372, segchgen3tv@aulss2.veneto.it
Elisa Antoniazzi, MD
- Not yet recruiting
Ospedale di Cattinara
Trieste, Italy, 34149
Nadia Renzi, MD, +39 040 3994258, nadia.renzi@asugi.sanita.fvg.it
Nadia Renzi, MD
- Not yet recruiting
Ospedale Universitario di Udine
Udine, Italy, 33100
Glenda Caputo, MD, +39 0432 559432, urp@policlinicoudine.it
Glenda Caputo, MD
- Not yet recruiting
Breast Unit Settelaghi
Varese, Italy, 21100
Francesca Rovera, MD, +39 0332 278111, francesca.rovera@uninsubria.it
Francesca Rovera, MD
About this study
Official title: Sexual Well-being of Women Undergoing Mastectomy and Reconstruction: a National Survey.
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.
- Being tested
- Survey using a questionnaire.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey using a questionnaire.Other
Questionnaires collecting sociodemographic information and their sexual well-being.
| Study group | Role | What they receive |
|---|---|---|
| Survey | Experimental | At 1-year follow-up, breast cancer patients who underwent mastectomy and reconstruction are asked to complete several questionnaires after the medical consultation collecting sociodemographic information and their sexual well-being. Receives: Other: Survey using a questionnaire. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sexual well-being
Sexual well-being, a multidimensional construct, will be assessed using a combination of validated and non-validated questionnaires. For each outcome score, descriptive statistics will be reported, including mean, standard deviation, median, and interquartile range. Comparisons of mean scores across predefined subgroups-such as type of reconstruction, systemic and local treatments, menopausal status, obesity, and parity-will be conducted using analysis of variance. A p-value < 0.05 will be considered statistically significant.
Measured: Enrollment visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start21 Jan 2026
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mastectomy and Breast ReconstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07234461
- Sponsor's protocol ID
- UID 4897
- Other IDs
- L2-367
- Status last verified
- Jan 2026
- First submitted
- 14 Nov 2025
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sexual Well-being of Women Undergoing Mastectomy and Reconstruction: a National Survey.
- ClinicalTrials.gov ID
- NCT07234461
- Acronym / sponsor ID
- UID 4897
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Study start
- 21 Jan 2026 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 18 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Survey | Experimental | Other: Survey using a questionnaire.At 1-year follow-up, breast cancer patients who underwent mastectomy and reconstruction are asked to complete several questionnaires after the medical consultation collecting sociodemographic information and their sexual well-being. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Survey using a questionnaire.Questionnaires collecting sociodemographic information and their sexual well-being. | Other | Survey |
Primary outcome
Sexual well-being
Time frame: Enrollment visit
Sexual well-being, a multidimensional construct, will be assessed using a combination of validated and non-validated questionnaires. For each outcome score, descriptive statistics will be reported, including mean, standard deviation, median, and interquartile range. Comparisons of mean scores across predefined subgroups-such as type of reconstruction, systemic and local treatments, menopausal status, obesity, and parity-will be conducted using analysis of variance. A p-value < 0.05 will be considered statistically significant.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Survey using a questionnaire. in people with Mastectomy and Breast Reconstruction and Sexual Wellness, run by European Institute of Oncology at 19 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Francesca De Lorenzi, MD (+39 0257489.394, francesca.delorenzi@ieo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sexual well-being (time frame: Enrollment visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026; AzTrials last refreshed its copy on 26 Oct 2026.