Allison M Quick1, Travis Dockter2, Jennifer Le-Rademacher2, Ritu Salani3, Catherine Hudson4, Andrew Hundley4, Shelby Terstriep5, Lauren Streicher6, Stephanie Faubion7, Charles L Loprinzi8, Jenell S Coleman9, Karen C Wang9, Maryam Lustberg10. 1. The Ohio State University Comprehensive Cancer Center, Arthur G. James Cancer Hospital, Columbus, OH, United States. Electronic address: Allison.quick@osumc.edu. 2. Department of Health Sciences Research, Mayo Clinic, Rochester, MN, United States. 3. David Geffen School of Medicine at UCLA, Los Angeles, CA, United States. 4. The Ohio State University Wexner Medical Center, Columbus, OH, United States. 5. Sanford Health, Fargo, ND, United States. 6. Feinberg School of Medicine, Northwestern Memorial Hospital, Chicago, IL, United States. 7. Mayo Clinic, Jacksonville, FL, United States. 8. Mayo Clinic, Rochester, MN, United States. 9. Johns Hopkins University School of Medicine, Baltimore, MD, United States. 10. The Ohio State University Comprehensive Cancer Center, Arthur G. James Cancer Hospital, Columbus, OH, United States.
Abstract
PURPOSE: The objectives of this study were to evaluate the feasibility and efficacy of fractional CO2 laser therapy in gynecologic cancer survivors. METHODS: This was a pilot, multi-institutional randomized sham-controlled trial of women with gynecologic cancers with dyspareunia and/or vaginal dryness. Participants were randomized to fractional CO2 laser treatment or sham laser treatment. The primary aim was to estimate the proportion of patients who had improvement in symptoms based on the Vaginal Assessment Scale (VAS). Secondary aims included changes in sexual function assessed using the Female Sexual Functioning Index (FSFI) and urinary symptoms assessed using the the Urinary Distress Inventory (UDI-6). RESULTS: Eighteen women participated in the study, ten in the treatment arm and eight in the sham arm. The majority of participants had stage I (n = 11, 61.1 %) or II (n = 3, 16.7 %) endometrial cancer with adenocarcinoma histology (n = 9, 50 %). In total, 15 (83.3 %) of the participants completed all treatments and follow-up visit. There was no difference in the change in the median VAS score from baseline to follow-up. However, there was an improvement in change in the median total FSFI score with treatment compared with sham (Δ 6.5 vs -0.3, p = 0.02). The change in the median UDI-6 score was lower in the treatment arm (Δ -14.6 vs -2.1, p = 0.17), but this was not statistically significant. There were no reported serious adverse events. CONCLUSIONS: Fractional CO2 laser therapy is feasible in gynecologic cancer survivors, with preliminary evidence of safety. In addition, there was preliminary evidence of improvement in sexual function compared with sham treatment. Clinicaltrial.gov Identifier: NCT03372720 (OSU-17261; NCI-2017-02051).
PURPOSE: The objectives of this study were to evaluate the feasibility and efficacy of fractional CO2 laser therapy in gynecologic cancer survivors. METHODS: This was a pilot, multi-institutional randomized sham-controlled trial of women with gynecologic cancers with dyspareunia and/or vaginal dryness. Participants were randomized to fractional CO2 laser treatment or sham laser treatment. The primary aim was to estimate the proportion of patients who had improvement in symptoms based on the Vaginal Assessment Scale (VAS). Secondary aims included changes in sexual function assessed using the Female Sexual Functioning Index (FSFI) and urinary symptoms assessed using the the Urinary Distress Inventory (UDI-6). RESULTS: Eighteen women participated in the study, ten in the treatment arm and eight in the sham arm. The majority of participants had stage I (n = 11, 61.1 %) or II (n = 3, 16.7 %) endometrial cancer with adenocarcinoma histology (n = 9, 50 %). In total, 15 (83.3 %) of the participants completed all treatments and follow-up visit. There was no difference in the change in the median VAS score from baseline to follow-up. However, there was an improvement in change in the median total FSFI score with treatment compared with sham (Δ 6.5 vs -0.3, p = 0.02). The change in the median UDI-6 score was lower in the treatment arm (Δ -14.6 vs -2.1, p = 0.17), but this was not statistically significant. There were no reported serious adverse events. CONCLUSIONS: Fractional CO2 laser therapy is feasible in gynecologic cancer survivors, with preliminary evidence of safety. In addition, there was preliminary evidence of improvement in sexual function compared with sham treatment. Clinicaltrial.gov Identifier: NCT03372720 (OSU-17261; NCI-2017-02051).
Authors: K Kirchheiner; E Fidarova; R A Nout; M P Schmid; A Sturdza; E Wiebe; A Kranz; S Polterauer; R Pötter; W Dörr Journal: Strahlenther Onkol Date: 2012-09-29 Impact factor: 3.621
Authors: Cynthia A Stuenkel; Susan R Davis; Anne Gompel; Mary Ann Lumsden; M Hassan Murad; JoAnn V Pinkerton; Richard J Santen Journal: J Clin Endocrinol Metab Date: 2015-10-07 Impact factor: 5.958
Authors: Allison M Quick; Andrew Hundley; Cynthia Evans; Julie A Stephens; Bhuvaneswari Ramaswamy; Raquel E Reinbolt; Anne M Noonan; Jeffrey Bryan Van Deusen; Robert Wesolowski; Daniel G Stover; Nicole Olivia Williams; Sagar D Sardesai; Stephanie S Faubion; Charles L Loprinzi; Maryam B Lustberg Journal: J Clin Med Date: 2022-01-31 Impact factor: 4.241