A single-arm, prospective trial investigating the effectiveness of a non-hormonal vaginal moisturizer containing hyaluronic acid in postmenopausal cancer survivors

Support Care Cancer. 2021 Jan;29(1):311-322. doi: 10.1007/s00520-020-05472-3. Epub 2020 May 2.

Abstract

Purpose: To assess the feasibility and efficacy of a non-hormonal hyaluronic acid (HLA) vaginal gel in improving vulvovaginal estrogen-deprivation symptoms in postmenopausal women with a history of hormone receptor-positive (HR+) cancer.

Methods: For this single-arm, prospective longitudinal trial, we identified disease-free patients with a history of HR+ breast cancer treated with aromatase inhibitors or HR+ endometrial cancer treated with surgery 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 101 patients, mean age was 55 years (range, 31-78), 68% (n = 69) were partnered, and 60% (n = 61) were sexually active. In linear mixed models, VAS/VuAS scores significantly improved at all assessment points (all p < 0.001). MSCL scores similarly improved (all p < 0.001). FSFI scores significantly improved from T1 to T2 (p < 0.03), T3 (p < 0.001), and T4 (p < 0.001). Severe vaginal pH (> 6.5) decreased from 26% at T1 to 19% at T4 (p = 0.18).

Conclusions: HLA moisturization improved vulvovaginal health/sexual function of cancer survivors. While HLA administration 1-2×/week is recommended for women in natural menopause, a 3-5×/week schedule appears to be more effective for symptom relief in cancer survivors.

Keywords: Breast cancer; Cancer survivorship; Endometrial cancer; Hyaluronic acid; Sexual function; Vaginal health.

MeSH terms

  • Adult
  • Aged
  • Aromatase Inhibitors / therapeutic use*
  • Atrophy
  • Breast Neoplasms / pathology
  • Breast Neoplasms / therapy
  • Cancer Survivors*
  • Endometrial Neoplasms / pathology
  • Endometrial Neoplasms / therapy
  • Female
  • Humans
  • Hyaluronic Acid / therapeutic use*
  • Longitudinal Studies
  • Middle Aged
  • Postmenopause / physiology
  • Prospective Studies
  • Vagina / pathology*
  • Vaginal Creams, Foams, and Jellies / therapeutic use
  • Vaginal Diseases / drug therapy*
  • Vulva / pathology*

Substances

  • Aromatase Inhibitors
  • Vaginal Creams, Foams, and Jellies
  • Hyaluronic Acid