drugset / Trial / NCT05585476
A Laser and Topical Treatment Combination in the Vulvo-vaginal Atrophy Management in Breast Cancer Patients.
Not yet recruiting
180 enrolled
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Lumenis Be Ltd. · collabMucosa Innovations, S.L. · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
The genito-urinary syndrome of menopause severely affects patients with a history of gynecological cancer, especially those diagnosed with breast cancer. At the present time, we do not have solid scientific evidence on treatments that can be effective and safe to address this pathology. Based on the above, we have developed our working hypothesis where it is postulated that the microfractionated laser treatment of C02, in conjunction with topical regenerative treatment, constitute an effective alternative in the management of vulvo-vaginal atrophy in oncological patients who have contraindicated hormonal treatments.
Timeline
- Start
- 2025-10
- Primary completion
- 2026-06
- Completion
- 2026-09
Publications
- Background Nappi RE, Particco M, Biglia N, Cagnacci A, Di Carlo C, Luisi S, Paoletti AM. Attitudes and perceptions towards vulvar and vaginal atrophy in Italian post-menopausal women: Evidence from the European REVIVE survey. Maturitas. 2016 Sep;91:74-80. doi: 10.1016/j.maturitas.2016.06.009. Epub 2016 Jun 11.
- Background Amori P, Di Nardo V, Vitiello G, Franca K, Hercogova J, Wollina U, Daaboul F, Tchernev G, Lotti T. Primavera: A new therapeutical approach to vulvo-vaginal atrophy. Dermatol Ther. 2018 Nov;31(6):e12678. doi: 10.1111/dth.12678. Epub 2018 Nov 8.
- Background Palma F, Xholli A, Cagnacci A; as the writing group of the AGATA study. The most bothersome symptom of vaginal atrophy: Evidence from the observational AGATA study. Maturitas. 2018 Feb;108:18-23. doi: 10.1016/j.maturitas.2017.11.007. Epub 2017 Nov 10.
- Background Gandhi J, Chen A, Dagur G, Suh Y, Smith N, Cali B, Khan SA. Genitourinary syndrome of menopause: an overview of clinical manifestations, pathophysiology, etiology, evaluation, and management. Am J Obstet Gynecol. 2016 Dec;215(6):704-711. doi: 10.1016/j.ajog.2016.07.045. Epub 2016 Jul 26.
- Background Mocan-Hognogi RF, Costin N, Malutan A, Ciortea R, Trif IA, Nagy AL, Bogdan ML, Mihu D. Histological changes in the vulva and vagina from ovariectomised rats undergoing oestrogen treatment. Folia Morphol (Warsz). 2016;75(4):467-473. doi: 10.5603/FM.a2016.0026. Epub 2016 Nov 10.
- Background Rozenberg S, Joris A, Albert V, Antoine C, Vandromme J. [La menopause et le traitement hormonal de la menopause : une actualisation]. Rev Med Brux. 2018;39(4):259-263. French.
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- Background Trinkaus M, Chin S, Wolfman W, Simmons C, Clemons M. Should urogenital atrophy in breast cancer survivors be treated with topical estrogens? Oncologist. 2008 Mar;13(3):222-31. doi: 10.1634/theoncologist.2007-0234.
- Background Sturdee DW, Panay N; International Menopause Society Writing Group. Recommendations for the management of postmenopausal vaginal atrophy. Climacteric. 2010 Dec;13(6):509-22. doi: 10.3109/13697137.2010.522875. Epub 2010 Sep 30.
- Background Pfeiler G, Glatz C, Konigsberg R, Geisendorfer T, Fink-Retter A, Kubista E, Singer CF, Seifert M. Vaginal estriol to overcome side-effects of aromatase inhibitors in breast cancer patients. Climacteric. 2011 Jun;14(3):339-44. doi: 10.3109/13697137.2010.529967. Epub 2011 Jan 13.
- Background Nappi RE, Palacios S, Particco M, Panay N. The REVIVE (REal Women's VIews of Treatment Options for Menopausal Vaginal ChangEs) survey in Europe: Country-specific comparisons of postmenopausal women's perceptions, experiences and needs. Maturitas. 2016 Sep;91:81-90. doi: 10.1016/j.maturitas.2016.06.010. Epub 2016 Jun 15.
- Background Palacios S, Castelo-Branco C, Currie H, Mijatovic V, Nappi RE, Simon J, Rees M. Update on management of genitourinary syndrome of menopause: A practical guide. Maturitas. 2015 Nov;82(3):308-13. doi: 10.1016/j.maturitas.2015.07.020. Epub 2015 Jul 26.
- Background Tadir Y, Gaspar A, Lev-Sagie A, Alexiades M, Alinsod R, Bader A, Calligaro A, Elias JA, Gambaciani M, Gaviria JE, Iglesia CB, Selih-Martinec K, Mwesigwa PL, Ogrinc UB, Salvatore S, Scollo P, Zerbinati N, Nelson JS. Light and energy based therapeutics for genitourinary syndrome of menopause: Consensus and controversies. Lasers Surg Med. 2017 Feb;49(2):137-159. doi: 10.1002/lsm.22637. Epub 2017 Feb 21.
- Background Gambacciani M, Cervigni M. Erbium laser in gynecology: aims, aspirations and action points. Climacteric. 2015;18 Suppl 1:2-3. doi: 10.3109/13697137.2015.1082258. No abstract available.
- Background Vizintin Z, Lukac M, Kazic M, Tettamanti M. Erbium laser in gynecology. Climacteric. 2015;18 Suppl 1:4-8. doi: 10.3109/13697137.2015.1078668.
- Background Salvatore S, Nappi RE, Zerbinati N, Calligaro A, Ferrero S, Origoni M, Candiani M, Leone Roberti Maggiore U. A 12-week treatment with fractional CO2 laser for vulvovaginal atrophy: a pilot study. Climacteric. 2014 Aug;17(4):363-9. doi: 10.3109/13697137.2014.899347. Epub 2014 Jun 5.
- Background Sokol ER, Karram MM. Use of a novel fractional CO2 laser for the treatment of genitourinary syndrome of menopause: 1-year outcomes. Menopause. 2017 Jul;24(7):810-814. doi: 10.1097/GME.0000000000000839.
- Background Siliquini GP, Tuninetti V, Bounous VE, Bert F, Biglia N. Fractional CO2 laser therapy: a new challenge for vulvovaginal atrophy in postmenopausal women. Climacteric. 2017 Aug;20(4):379-384. doi: 10.1080/13697137.2017.1319815. Epub 2017 May 15.
- Background Gaspar A, Brandi H, Gomez V, Luque D. Efficacy of Erbium:YAG laser treatment compared to topical estriol treatment for symptoms of genitourinary syndrome of menopause. Lasers Surg Med. 2017 Feb;49(2):160-168. doi: 10.1002/lsm.22569. Epub 2016 Aug 22.
- Background Antonino P, Gloria C. A new approach to treatment of vulvo-vaginal atrophy. Maturitas. 2015 Aug;81(4):499. doi: 10.1016/j.maturitas.2015.03.003. Epub 2015 Mar 11. No abstract available.
- Background Filippini M, Del Duca E, Negosanti F, Bonciani D, Negosanti L, Sannino M, Cannarozzo G, Nistico SP. Fractional CO2 Laser: From Skin Rejuvenation to Vulvo-Vaginal Reshaping. Photomed Laser Surg. 2017 Mar;35(3):171-175. doi: 10.1089/pho.2016.4173. Epub 2016 Dec 30.
- Background Murina F, Karram M, Salvatore S, Felice R. Fractional CO2 Laser Treatment of the Vestibule for Patients with Vestibulodynia and Genitourinary Syndrome of Menopause: A Pilot Study. J Sex Med. 2016 Dec;13(12):1915-1917. doi: 10.1016/j.jsxm.2016.10.006. Epub 2016 Nov 15.
- Background Hutchinson-Colas J, Segal S. Genitourinary syndrome of menopause and the use of laser therapy. Maturitas. 2015 Dec;82(4):342-5. doi: 10.1016/j.maturitas.2015.08.001. Epub 2015 Aug 12.
- Background Rabley A, O'Shea T, Terry R, Byun S, Louis Moy M. Laser Therapy for Genitourinary Syndrome of Menopause. Curr Urol Rep. 2018 Aug 17;19(10):83. doi: 10.1007/s11934-018-0831-y.
- Background Salvatore S, Nappi RE, Parma M, Chionna R, Lagona F, Zerbinati N, Ferrero S, Origoni M, Candiani M, Leone Roberti Maggiore U. Sexual function after fractional microablative CO(2) laser in women with vulvovaginal atrophy. Climacteric. 2015 Apr;18(2):219-25. doi: 10.3109/13697137.2014.975197. Epub 2014 Dec 16.
- Background Sokol ER, Karram MM. An assessment of the safety and efficacy of a fractional CO2 laser system for the treatment of vulvovaginal atrophy. Menopause. 2016 Oct;23(10):1102-7. doi: 10.1097/GME.0000000000000700.
- Background Behnia-Willison F, Sarraf S, Miller J, Mohamadi B, Care AS, Lam A, Willison N, Behnia L, Salvatore S. Safety and long-term efficacy of fractional CO2 laser treatment in women suffering from genitourinary syndrome of menopause. Eur J Obstet Gynecol Reprod Biol. 2017 Jun;213:39-44. doi: 10.1016/j.ejogrb.2017.03.036. Epub 2017 Apr 2.
- Background Perino A, Calligaro A, Forlani F, Tiberio C, Cucinella G, Svelato A, Saitta S, Calagna G. Vulvo-vaginal atrophy: a new treatment modality using thermo-ablative fractional CO2 laser. Maturitas. 2015 Mar;80(3):296-301. doi: 10.1016/j.maturitas.2014.12.006. Epub 2014 Dec 25.
- Background Perino A, Cucinella G, Gugliotta G, Saitta S, Polito S, Adile B, Marci R, Calagna G. Is vaginal fractional CO2 laser treatment effective in improving overactive bladder symptoms in post-menopausal patients? Preliminary results. Eur Rev Med Pharmacol Sci. 2016 Jun;20(12):2491-7.
- Background Pitsouni E, Grigoriadis T, Tsiveleka A, Zacharakis D, Salvatore S, Athanasiou S. Microablative fractional CO2-laser therapy and the genitourinary syndrome of menopause: An observational study. Maturitas. 2016 Dec;94:131-136. doi: 10.1016/j.maturitas.2016.09.012. Epub 2016 Sep 16.
- Background Gonzalez Isaza P, Jaguszewska K, Cardona JL, Lukaszuk M. Long-term effect of thermoablative fractional CO2 laser treatment as a novel approach to urinary incontinence management in women with genitourinary syndrome of menopause. Int Urogynecol J. 2018 Feb;29(2):211-215. doi: 10.1007/s00192-017-3352-1. Epub 2017 May 18.
- Background Athanasiou S, Pitsouni E, Antonopoulou S, Zacharakis D, Salvatore S, Falagas ME, Grigoriadis T. The effect of microablative fractional CO2 laser on vaginal flora of postmenopausal women. Climacteric. 2016 Oct;19(5):512-8. doi: 10.1080/13697137.2016.1212006. Epub 2016 Aug 24.
- Background Pitsouni E, Grigoriadis T, Falagas ME, Salvatore S, Athanasiou S. Laser therapy for the genitourinary syndrome of menopause. A systematic review and meta-analysis. Maturitas. 2017 Sep;103:78-88. doi: 10.1016/j.maturitas.2017.06.029. Epub 2017 Jun 27.
- Background Flint R, Cardozo L, Grigoriadis T, Rantell A, Pitsouni E, Athanasiou S. Rationale and design for fractional microablative CO2 laser versus photothermal non-ablative erbium:YAG laser for the management of genitourinary syndrome of menopause: a non-inferiority, single-blind randomized controlled trial. Climacteric. 2019 Jun;22(3):307-311. doi: 10.1080/13697137.2018.1559806. Epub 2019 Jan 24.
- Background Escribano JJ, Gonzalez-Isaza P, Tserotas K, Athanasiou S, Zerbinati N, Leibaschoff G, Salvatore S, Sanchez-Borrego R. In response to the FDA warning about the use of photomedicine in gynecology. Lasers Med Sci. 2019 Sep;34(7):1509-1511. doi: 10.1007/s10103-019-02744-1. Epub 2019 Mar 4.
- Background Lester J, Pahouja G, Andersen B, Lustberg M. Atrophic vaginitis in breast cancer survivors: a difficult survivorship issue. J Pers Med. 2015 Mar 25;5(2):50-66. doi: 10.3390/jpm5020050.
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- Background Kingsberg SA, Krychman M, Graham S, Bernick B, Mirkin S. The Women's EMPOWER Survey: Identifying Women's Perceptions on Vulvar and Vaginal Atrophy and Its Treatment. J Sex Med. 2017 Mar;14(3):413-424. doi: 10.1016/j.jsxm.2017.01.010. Epub 2017 Feb 12.
- Background Kingsberg SA, Larkin L, Krychman M, Parish SJ, Bernick B, Mirkin S. WISDOM survey: attitudes and behaviors of physicians toward vulvar and vaginal atrophy (VVA) treatment in women including those with breast cancer history. Menopause. 2019 Feb;26(2):124-131. doi: 10.1097/GME.0000000000001194.
- Background Kingsberg SA, Krychman ML. Resistance and barriers to local estrogen therapy in women with atrophic vaginitis. J Sex Med. 2013 Jun;10(6):1567-74. doi: 10.1111/jsm.12120. Epub 2013 Mar 27.
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- Background Sinha A, Ewies AA. Non-hormonal topical treatment of vulvovaginal atrophy: an up-to-date overview. Climacteric. 2013 Jun;16(3):305-12. doi: 10.3109/13697137.2012.756466. Epub 2013 Jan 8.
- Background Dezzutti CS, Brown ER, Moncla B, Russo J, Cost M, Wang L, Uranker K, Kunjara Na Ayudhya RP, Pryke K, Pickett J, Leblanc MA, Rohan LC. Is wetter better? An evaluation of over-the-counter personal lubricants for safety and anti-HIV-1 activity. PLoS One. 2012;7(11):e48328. doi: 10.1371/journal.pone.0048328. Epub 2012 Nov 7.
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- Background Becorpi A, Campisciano G, Zanotta N, Tredici Z, Guaschino S, Petraglia F, Pieralli A, Sisti G, De Seta F, Comar M. Fractional CO2 laser for genitourinary syndrome of menopause in breast cancer survivors: clinical, immunological, and microbiological aspects. Lasers Med Sci. 2018 Jul;33(5):1047-1054. doi: 10.1007/s10103-018-2471-3. Epub 2018 Mar 1.
- Background Pieralli A, Fallani MG, Becorpi A, Bianchi C, Corioni S, Longinotti M, Tredici Z, Guaschino S. Fractional CO2 laser for vulvovaginal atrophy (VVA) dyspareunia relief in breast cancer survivors. Arch Gynecol Obstet. 2016 Oct;294(4):841-6. doi: 10.1007/s00404-016-4118-6. Epub 2016 May 12.
- Background Pagano T, De Rosa P, Vallone R, Schettini F, Arpino G, Giuliano M, Lauria R, De Santo I, Conforti A, Gallo A, Nazzaro G, De Placido S, Locci M, De Placido G. Fractional microablative CO2 laser in breast cancer survivors affected by iatrogenic vulvovaginal atrophy after failure of nonestrogenic local treatments: a retrospective study. Menopause. 2018 Jun;25(6):657-662. doi: 10.1097/GME.0000000000001053.
- Background Leone Roberti Maggiore U, Parma M, Candiani M, Salvatore S. Microablative Fractional CO2 Laser for Vulvovaginal Atrophy in Women With a History of Breast Cancer. J Minim Invasive Gynecol. 2015 Nov-Dec;22(6S):S100. doi: 10.1016/j.jmig.2015.08.269. Epub 2015 Oct 15. No abstract available.
- Background Jha S, Wyld L, Krishnaswamy PH. The Impact of Vaginal Laser Treatment for Genitourinary Syndrome of Menopause in Breast Cancer Survivors: A Systematic Review and Meta-analysis. Clin Breast Cancer. 2019 Aug;19(4):e556-e562. doi: 10.1016/j.clbc.2019.04.007. Epub 2019 Apr 19.
- Background Gambacciani M, Levancini M, Cervigni M. Vaginal erbium laser: the second-generation thermotherapy for the genitourinary syndrome of menopause. Climacteric. 2015 Oct;18(5):757-63. doi: 10.3109/13697137.2015.1045485.
- Background Robinson D, Flint R, Veit-Rubin N, Araklitis G, Cardozo L. Is there enough evidence to justify the use of laser and other thermal therapies in female lower urinary tract dysfunction? Report from the ICI-RS 2019. Neurourol Urodyn. 2020 Jul;39 Suppl 3:S140-S147. doi: 10.1002/nau.24298. Epub 2020 Feb 10.
- Background Alvisi S, Baldassarre M, Martelli V, Gava G, Seracchioli R, Meriggiola MC. Effects of ospemifene on vaginal epithelium of post-menopausal women. Gynecol Endocrinol. 2017 Dec;33(12):946-950. doi: 10.1080/09513590.2017.1332589. Epub 2017 May 31.
- Background Alvisi S, Baldassarre M, Gava G, Mancini I, Gagliardi M, Seracchioli R, Meriggiola MC. Structure of Epithelial and Stromal Compartments of Vulvar and Vaginal Tissue From Women With Vulvo-Vaginal Atrophy Taking Ospemifene. J Sex Med. 2018 Dec;15(12):1776-1784. doi: 10.1016/j.jsxm.2018.10.009. Epub 2018 Nov 13.