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

Gynecol Oncol. 2020 Aug;158(2):366-374. doi: 10.1016/j.ygyno.2020.05.025. Epub 2020 Jun 8.

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.

Keywords: Endometrial cancer; Hyaluronic acid; Non-hormonal vaginal moisturizer; Sexual function; Vaginal health; Vulvar health.

Publication types

  • Clinical Trial
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Cancer Survivors
  • Cohort Studies
  • Endometrial Neoplasms / physiopathology
  • Endometrial Neoplasms / radiotherapy
  • Endometrial Neoplasms / rehabilitation*
  • Endometrial Neoplasms / surgery
  • Female
  • Humans
  • Hyaluronic Acid / administration & dosage*
  • Longitudinal Studies
  • Middle Aged
  • Prospective Studies
  • Vagina / drug effects*
  • Vagina / physiopathology
  • Vaginal Creams, Foams, and Jellies / administration & dosage*
  • Vulva / drug effects*
  • Vulva / physiopathology

Substances

  • Vaginal Creams, Foams, and Jellies
  • Hyaluronic Acid