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Recruiting NCT07234461

Sexual Well-being of Women Undergoing Mastectomy and Reconstruction

Trial Parameters

Condition Mastectomy and Breast Reconstruction
Sponsor European Institute of Oncology
Study Type INTERVENTIONAL
Phase N/A
Enrollment 200
Sex FEMALE
Min Age 18 Years
Max Age N/A
Start Date 2026-01-21
Completion 2026-10
Interventions
Survey using a questionnaire.

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.

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