A single-arm clinical trial investigating the effectiveness of a non-hormonal, hyaluronic acid-based vaginal moisturizer in endometrial cancer survivors Journal Article
| Authors: | Carter, J.; Goldfarb, S.; Baser, R. E.; Goldfrank, D. J.; Seidel, B.; Milli, L.; Saban, S.; Stabile, C.; Canty, J.; Gardner, G. J.; Jewell, E. L.; Sonoda, Y.; Kollmeier, M. A.; Alektiar, K. M. |
| Article Title: | A single-arm clinical trial investigating the effectiveness of a non-hormonal, hyaluronic acid-based vaginal moisturizer in endometrial cancer survivors |
| Abstract: | Objective: To assess the efficacy of non-hormonal, hyaluronic acid (HLA)-based vaginal gel in improving vulvovaginal estrogen-deprivation symptoms in women with a history of endometrial cancer. Methods: For this single-arm, prospective, longitudinal trial, we enrolled disease-free women with a history of endometrial cancer who underwent surgery (total hysterectomy) and postoperative radiation. Participants used HLA daily for the first 2 weeks, and then 3×/week until weeks 12–14; dosage was then increased to 5×/week for non-responders. Vulvovaginal symptoms and pH were assessed at 4 time points (baseline [T1]; 4–6 weeks [T2]; 12–14 weeks [T3]; 22–24 weeks [T4]) with clinical evaluation, the Vaginal Assessment Scale (VAS), Vulvar Assessment Scale (VuAS), Female Sexual Function Index (FSFI), and Menopausal Symptom Checklist (MSCL). Results: Of 43 patients, mean age was 59 years (range, 38–78); 54% (23/43) were partnered; and 49% (21/43) were sexually active. VAS, VuAS, MSCL, and SAQ (Sexual Activity Questionnaire) scores significantly improved from baseline to each assessment point (all p <.002). FSFI total mean scores significantly increased from T1 to T2 (p <.05) and from T1 to T4 (p <.03). At T1, 41% (16/39) felt confident about future sexual activity compared to 68% (17/25) at T4 (p =.096). Severely elevated vaginal pH (>6.5) decreased from 30% (13/43) at T1 to 19% (5/26) at T4 (p =.41). Conclusion: The HLA-based gel improved vulvovaginal health and sexual function of endometrial cancer survivors in perceived symptoms and clinical exam outcomes. HLA administration 1–2×/week is recommended for women in natural menopause; a 3–5×/week schedule appears more effective for symptom relief in cancer survivors. © 2020 Elsevier Inc. |
| Keywords: | adult; clinical article; controlled study; aged; clinical trial; drug efficacy; treatment duration; cancer radiotherapy; comparative study; endometrial cancer; hysterectomy; endometrium cancer; prospective study; clinical assessment; estrogen; bedtime dosage; dyspareunia; vaginal dryness; cancer survivor; gel; sexuality; clinical evaluation; therapy effect; clinical effectiveness; hyaluronic acid; sexual function; sexual behavior; longitudinal study; vaginal health; medical history; female sexual function index; vagina atrophy; human; female; priority journal; article; vulvovaginal disease; genital system disease assessment; sexual activity questionnaire; vagina ph; vaginal assessment scale; gelation; vulvar health; vulvar assessment scale; non-hormonal vaginal moisturizer; hyaluronic acid derivative; propylene glycol; sodium hydroxide; menopausal symptom checklist; vulvovaginal discomfort |
| Journal Title: | Gynecologic Oncology |
| Volume: | 158 |
| Issue: | 2 |
| ISSN: | 0090-8258 |
| Publisher: | Elsevier Inc. |
| Date Published: | 2020-08-01 |
| Start Page: | 366 |
| End Page: | 374 |
| Language: | English |
| DOI: | 10.1016/j.ygyno.2020.05.025 |
| PUBMED: | 32522420 |
| PROVIDER: | scopus |
| PMCID: | PMC7423634 |
| DOI/URL: | |
| Notes: | Article -- Export Date: 1 September 2020 -- Source: Scopus |
