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

Carter, Jeanne; Baser, Raymond E.; Goldfrank, Deborah J.; Seidel, Barbara; Milli, Lisania; Stabile, Cara; Canty, Jocelyn; Saban, Sally; Goldfarb, Shari; Dickler, Maura N.; Gardner, Ginger J.; Jewell, Elizabeth L.; Sonoda, Yukio; Alektiar, Kaled M.

doi:10.1007/s00520-020-05472-3

Cited by 29 publications

(25 citation statements)

References 21 publications

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“…A total of 11 studies (8 RCTs and 3 before-after studies) tested topical interventions. Seven studies assessed the efficacy of nonhormonal vaginal gels and moisturizer with mixed results 40-44,49 . Two RCTs (low risk of bias) that evaluated pH-balanced vaginal gels presented contradicting results, with the most recent study suggesting no improvements to sexual dysfunction when compared to control 40,41 .…”

Section: Resultsmentioning

confidence: 99%

“…One cross-over trial that compared water- and silicone- based lubricants (concerning risk of bias) found significant benefit on functional well-being in the silicone arm, though no difference in sexual outcome changes was observed between arms 43 . A before-after trial (poor quality) of nonhormonal hyaluronic acid gel showed efficacy in improving vaginal health and function 49 . Another before-after trial (fair quality) of vaginal moisturizing cream provided benefits for all hypo- estrogenic vulvovaginal symptoms, except for discharge 48 …”

Section: Resultsmentioning

confidence: 99%

“…Non-hormonal topical preparations, predominantly vaginal gel or cream, were of limited benefit 40,44,49 . These treatments are often chosen as a safe first-line option in treating hypo- estrogenic vulvovaginal symptoms in cancer survivors 41 .…”

Section: Discussionmentioning

confidence: 99%

“…Seven studies assessed the efficacy of nonhormonal vaginal gels and moisturizer with mixed results. [40][41][42][43][44]49 Two RCTs (low risk of bias) that evaluated pHbalanced vaginal gels presented contradicting results, with the most recent study suggesting no improvements to sexual dysfunction when compared to control. 40,41 One study (high risk of bias) found no significant improvement of sexual function with use of polyacrylic acid vaginal moisturizer compared to control, with comparable improvement over time in all arms.…”

Section: Topical Interventionmentioning

confidence: 99%

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Efficacy of interventions to manage sexual dysfunction in women with cancer: a systematic review

et al. 2022

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Importance: Cancer and its treatment negatively affect female sexual health and function. The prevalence of female sexual dysfunction after cancer is between 33% and 43%. Numerous studies have addressed treatment options for sexual dysfunction in women with cancer, but it still remains a challenge to select the most efficacious option for patients.Objective: To compile and appraise recent evidence of any interventions for managing sexual dysfunction in female cancer survivors.Evidence Review: A literature search of the electronic databases MEDLINE, EMBASE, PsycINFO, and Cochrane Central Register of Controlled Trials (January 2011 to February 2021) was conducted using general search terms of ''women'', ''cancer'', ''intervention'', ''sexual dysfunction''. We included randomized controlled trials (RCTs) and uncontrolled before-after studies that evaluated the efficacy of intervention for female sexual dysfunction in women with history of cancer. Methodological quality of studies was assessed using Risk of Bias (RoB) 2.0 for RCTs and National Institutes of Health (NIH) assessment tools for uncontrolled before-after studies.Findings: Thirty-six studies were included for qualitative synthesis (14 RCTs (n ¼ 1284), 17 uncontrolled trials (n ¼ 589), and 5 cohort studies (n ¼ 497). Only four studies were at low risk of bias. Topical interventions (vaginal gels or creams) were able to alleviate vaginal dryness and dyspareunia, with intravaginal dehydroepiandrosterone (DHEA) (6.5 mg) gel showing evidence of improved sexual function. Evidence for estriol-lactobacilli vaginal tablets was unreliable due to a small-scale study. Psychoeducational therapy (internet-based cognitive behavioral therapy [CBT]) studies typically were at high risk of bias, but all displayed significant improvements of sexual function. Both laser therapy (fractional CO 2 and erbium) and multimodal approach studies were at concerning risk of bias, although suggesting beneficial effects on sexual function.Conclusions and Relevance: The most reliable evidence for improvement was from a study of DHEA vaginal gel, but in general, gels or creams were useful in reducing dyspareunia. Pharmacological, psychoeducational, laser therapy, and multimodal approaches demonstrated potential in managing cancer-related sexual issues, but most were small in size (10-70 participants), with moderate to high risk of bias. Therefore, large-scale, double-blind, RCTs with long-period follow-up, and at low risk of bias are needed to show efficacy for these interventions.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Topical Interventionmentioning

confidence: 99%

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Efficacy of interventions to manage sexual dysfunction in women with cancer: a systematic review

et al. 2022

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“…improved the vulvovaginal health/sexual function of cancer survivors. While HLA administration at 1-2×/week is recommended for women in natural menopause, a 3-5×/week schedule appeared to be more effective for symptom relief in cancer survivors[ 122 ]. One year earlier, these authors demonstrated that the HLA-based gel improved vulvovaginal health and sexual function in 43 endometrial cancer survivors in their perceived symptoms and clinical exam outcomes[ 123 ].…”

Section: Current Treatment Options For Genitourinary Syndrome Of Meno...mentioning

confidence: 99%

Management of genitourinary syndrome of menopause in breast cancer survivors: An update

López¹

2022

WJCO

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There is increasing attention about managing the adverse effects of adjuvant therapy (Chemotherapy and anti-estrogen treatment) for breast cancer survivors (BCSs). Vulvovaginal atrophy (VVA), caused by decreased levels of circulating estrogen to urogenital receptors, is commonly experienced by this patients. Women receiving antiestrogen therapy, specifically aromatase inhibitors, often suffer from vaginal dryness, itching, irritation, dyspareunia, and dysuria, collectively known as genitourinary syndrome of menopause (GSM), that it can in turn lead to pain, discomfort, impairment of sexual function and negatively impact on multiple domains of quality of life (QoL). The worsening of QoL in these patients due to GSM symptoms can lead to discontinuation of hormone adjuvant therapies and therefore must be addressed properly. The diagnosis of VVA is confirmed through patient-reported symptoms and gynecological examination of external structures, introitus, and vaginal mucosa. Systemic estrogen treatment is contraindicated in BCSs. In these patients, GSM may be prevented, reduced and managed in most cases but this requires early recognition and appropriate treatment, but it is normally undertreated by oncologists because of fear of cancer recurrence, specifically when considering treatment with vaginal estrogen therapy (VET) because of unknown levels of systemic absorption of estradiol. Lifestyle modifications and nonhormonal treatments (vaginal moisturizers, lubricants, and gels) are the first-line treatment for GSM both in healthy women as BCSs, but when these are not effective for symptom relief, other options can be considered, such as VET, ospemifene, local androgens, intravaginal dehydroepiandrosterone (prasterone), or laser therapy (erbium or CO2 Laser). The present data suggest that these therapies are effective for VVA in BCSs; however, safety remains controversial and a there is a major concern with all of these treatments. We review current evidence for various nonpharmacologic and pharmacologic therapeutic modalities for GSM in BCSs and highlight the substantial gaps in the evidence for safe and effective therapies and the need for future research. We include recommendations for an approach to the management of GSM in women at high risk for breast cancer, women with estrogen-receptor positive breast cancers, women with triple-negative breast cancers, and women with metastatic disease.

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Sexual and Reproductive Health Concerns

Shelby

Coleman

Arthur

et al. 2021

Common Issues in Breast Cancer Survivors

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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

Cited by 29 publications

References 21 publications

Efficacy of interventions to manage sexual dysfunction in women with cancer: a systematic review

Efficacy of interventions to manage sexual dysfunction in women with cancer: a systematic review

Management of genitourinary syndrome of menopause in breast cancer survivors: An update

Sexual and Reproductive Health Concerns

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