Pilot project on individualized management of genitourinary syndrome in menopause in women after oncological treatment

Treatment of gynecological cancers is often multimodal, involving surgical intervention (hysterectomy with bilateral salpingo-oophorectomy), systemic therapy, and radiation therapy, which can lead to menopause. This hypoestrogenic state can result in menopausal symptoms and negatively impact quality of life and sexuality. Similarly, patients undergoing treatment for breast cancer who receive antiestrogen drugs that mimic menopausal conditions or undergo bilateral salpingo-oophorectomy as part of their treatment face similar challenges. The hypoestrogenic state leads to the so-called genitourinary syndrome of menopause (GSM), where patients often report problems related to vaginal dryness and subsequently, sexual function difficulties. The gold standard for alleviating GSM and vaginal dryness issues is estrogen replacement therapy (either systemic or topical). However, depending on the histological type of malignant disease, when malignancies are hormone-dependent, estrogen replacement therapy is contraindicated in these patients. Non-pharmacological relief for GSM and vaginal dryness issues can be offered to patients with hormone-dependent malignancies. In the project, we will include 150 patients with gy11ecological and breast cancer who are in menopause due to oncological treatment and have accompanying GSM and vaginal dryness issues. The patients will be randomly divided into three groups. The control group of patients will receive standard support and rehabilitation related to GSM at the Institute of Oncology Ljubljana by a selected oncologist or gynecologist. Approximately 75 patients will be included in this group. The research group will be divided into two subgroups. The first subgroup will undergo treatment for vaginal dryness with non-ablative vaginal erbium laser. The second subgroup will undergo treatment for vaginal dryness using a vaginal lubricant containing peptides, niacinamide, and hyaluronic acid. The effects of the treatment will be evaluated objectively and subjectively, before and after the completion of GSM treatment. Subjectively, through questionnaires that the patients will complete before and after the completion of GSM treatment. Objectively, through histological and cytological assessment of vaginal mucosa, as well as assessment of elasticity, fluid volume, moisture, pH, and epithelial integrity (VHI-Vaginal Health Index).