A single-arm clinical trial investigating the effectiveness of a non-hormonal, hyaluronic acid-based vaginal moisturizer in endometrial cancer survivors

• Published in: Gynecologic oncology Vol. 158; no. 2; pp. 366 - 374
• Main Authors: Carter, Jeanne, Goldfarb, Shari, Baser, Raymond E., Goldfrank, Deborah J., Seidel, Barbara, Milli, Lisania, Saban, Sally, Stabile, Cara, Canty, Jocelyn, Gardner, Ginger J., Jewell, Elizabeth L., Sonoda, Yukio, Kollmeier, Marisa A., Alektiar, Kaled M.
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01-08-2020
• Subjects: Adult; Aged; Cancer Survivors; Cohort Studies; Endometrial cancer; Endometrial Neoplasms - physiopathology; Endometrial Neoplasms - radiotherapy; Endometrial Neoplasms - rehabilitation; Endometrial Neoplasms - surgery; Female; Humans; Hyaluronic acid; Hyaluronic Acid - administration & dosage; Longitudinal Studies; Middle Aged; Non-hormonal vaginal moisturizer; Prospective Studies; Sexual function; Vagina - drug effects; Vagina - physiopathology; Vaginal Creams, Foams, and Jellies - administration & dosage; Vaginal health; Vulva - drug effects; Vulva - physiopathology; Vulvar health; Vulvar health; Endometrial cancer; Hyaluronic acid; Non-hormonal vaginal moisturizer; Vaginal health; Sexual function
• ISSN: 0090-8258; 1095-6859
• DOI: 10.1016/j.ygyno.2020.05.025

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.
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).
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).
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.
•To evaluate the efficacy of HLA vaginal gel in improving vulvovaginal symptoms in endometrial cancer survivors•HLA vaginal moisturizing gel applied intravaginally and topically to the vulva improved vulvovaginal health.•HLA needs to be used at a higher frequency (3–5×/week) than recommended for general menopause (1–2×/week).•Improvements in vulvovaginal tissue quality enhanced sexual function and confidence and reduced menopausal symptoms.