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

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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.

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Funding

Fidia Pharmaceuticals supported the scientific aims of this clinical trial through the donation of product (Hydeal-D©) and a small research grant to MSK to cover the time and effort of an MSK statistician, research assistant, and pharmacy staff member for product distribution. This research was also funded in part through the National Institutes of Health Cancer Center Support Grant P30 CA008748.

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Correspondence to Jeanne Carter.

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Conflict of interest

Fidia Pharmaceuticals supported the scientific aims of this clinical trial through the donation of product (Hydeal-D©) and a small research grant to MSK to cover the time and effort of an MSK statistician, research assistant, and pharmacy staff member for product distribution. This research was also funded in part through the National Institutes of Health Cancer Center Support Grant P30 CA008748. Outside the submitted work, Dr. Jewell reports personal fees from Covidien/Medtronic.

Research involving human participants

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional review board and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

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Informed consent was obtained from all individual participants included in the study.

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Carter, J., Baser, R.E., Goldfrank, D.J. et al. A single-arm, prospective trial investigating the effectiveness of a non-hormonal vaginal moisturizer containing hyaluronic acid in postmenopausal cancer survivors. Support Care Cancer 29, 311–322 (2021). https://doi.org/10.1007/s00520-020-05472-3

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  • DOI: https://doi.org/10.1007/s00520-020-05472-3

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