Sexual and Vaginal Health in Breast Cancer Women Receiving Aromatase Inhibitors Before and After CO2 Laser Therapy

Background: Vulvovaginal health, directly linked to sexual health, is a key factor for female pleasure. BCS receiving AI are likely to present severe GSM and sexual complaints. Innovative options, as vaginal laser therapy, are emerging to treat GSM and sexual dysfunctions. Nowadays, data in BCS is scarce, moreover, few studies included patients receiving AI \[16\]. Different meta-analysis \[17-23\] found GSM \[24, 25\] and sexual function \[9, 10\] may improve significantly at short-term, however, the body of evidence is of low quality. Therefore, before recommendation of laser therapy for sexual complaints in BCS with GSM, there are unmet needs to be solved: efficacy and safety at long-term, biases related to patients' expectations and a detailed assessment of the complex underpinnings of sexuality. Aims: To evaluate sexual and vaginal health in BCS receiving AI with GSM, before and after CO2 laser therapy compared to a sham-controlled group. Methods: Prospective, randomized, double-blind controlled study with two parallel study arms: 1) Fractional CO2 laser therapy (5monthly sessions). 2) Sham laser therapy (5monthly sessions). After end-treatment, patients are followed up at 1 month and 6 months. BCS treated or undergoing AI with GSM and sexual function impairment, will be suitable. All patients will maintain first-line non-hormonal treatment and sexual assessment (PLISSIT Model) according with usual care. The primary outcome is improvement in sexual function (FSFI total score). As secondary outcomes: resumption sexual activity, sexual activity frequency, dyspareunia (VAS), female sexual dysfunction, sexual dimensions (FSFI), body image (S-BIS), quality of life (SF-12), vaginal pH acidification, maturation index and Vaginal Health Index of Gloria Backmann, adverse events, satisfaction (Likert scale) and adherence to treatment. Expected impact: Emergent, non-invasive, laser therapy has significant benefit for BCS with AI, improving subjective and objective sexual and vaginal health outcomes and adding value to the usual care multidisciplinary approach.

Sex

Female

Minimum age

30 Years

Maximum age

80 Years

Inclusion Criteria:

* BC treated with aromatase inhibitors ± GnRH analogues (aGnRH)
* Menopause (natural or induced) and signs / symptoms of GSM
* Vaginal pH ≥5
* Negative Human Papillomavirus (HPV) cytology and / or determination
* Intention or willingness to have sex
* Signed informed consent

Exclusion Criteria:

* Vaginal hormonal treatment in the last 6 months
* Vaginal moisturizers and / or lubricants during the 30 days prior to study treatment
* Laser treatment, radiofrequency, hyaluronic acid, lipofilling in the vagina during the last 2 years
* Ospemifene treatment
* Being affected for: active infection of the genital tract; intraepithelial neoplasm of cervix, vagina, or vulva; have or have been treated for genital cancer
* Genital prolapse stage ≥II.

• DERIVEDMension E, Alonso I, Angles-Acedo S, Ros C, Otero J, Villarino A, Farre R, Saco A, Vega N, Castrejon N, Ordi J, Rakislova N, Tortajada M, Matas I, Gomez S, Ribera L, Castelo-Branco C. Effect of Fractional Carbon Dioxide vs Sham Laser on Sexual Function in Survivors of Breast Cancer Receiving Aromatase Inhibitors for Genitourinary Syndrome of Menopause: The LIGHT Randomized Clinical Trial. JAMA Netw Open. 2023 Feb 1;6(2):e2255697. doi: 10.1001/jamanetworkopen.2022.55697. PMID 36763359