NCT07234461 Sexual Well-being of Women Undergoing Mastectomy and Reconstruction
| NCT ID | NCT07234461 |
| Status | Recruiting |
| Phase | — |
| Sponsor | European Institute of Oncology |
| Condition | Mastectomy and Breast Reconstruction |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2026-01-21 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2026-01-21 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: * 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). Exclusion Criteria: * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07234461 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Mastectomy and Breast Reconstruction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07234461 currently recruiting?
Yes, NCT07234461 is actively recruiting participants. Contact the research team at francesca.delorenzi@ieo.it for enrollment information.
Where is the NCT07234461 trial being conducted?
This trial is being conducted at Bari, Italy, Bari, Italy, Bologna, Italy, Cesena, Italy and 11 additional locations.
Who is sponsoring the NCT07234461 clinical trial?
NCT07234461 is sponsored by European Institute of Oncology. The trial plans to enroll 200 participants.