Sexual Health Support for Breast Cancer
Recruiting in Palo Alto (17 mi)
+6 other locations
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Memorial Sloan Kettering Cancer Center
Must be taking: Ovarian suppression, Endocrine therapy
Disqualifiers: Postmenopausal, High urogenital symptoms
No Placebo Group
Trial Summary
What is the purpose of this trial?
Researchers are doing this study to look at whether sexual health counselling and using non-hormonal moisturizer at the start of ovarian suppression may be able to prevent or reduce side effects such as vaginal dryness and sexual dysfunction. Researchers will compare how effective this prevention intervention works compared to the usual approach, which is to treat these side effects after they start. All participants will also complete surveys about their sexual health. This information will help researchers learn more about the sexual health of women with breast cancer receiving ovarian suppression.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, since the trial involves starting ovarian suppression and endocrine therapy, it's best to discuss your current medications with the trial team.
What data supports the effectiveness of the treatment Sexual Health Support for Breast Cancer?
Research shows that non-hormonal vaginal moisturizers can help improve symptoms of vaginal dryness and sexual satisfaction in breast cancer survivors, although the benefits may be temporary. Additionally, educational and counseling interventions have been found to consistently improve various aspects of sexual health.12345
Is the non-hormonal vaginal moisturizer safe for use in humans?
Research shows that non-hormonal vaginal moisturizers are generally safe for use in humans, with studies indicating no significant changes in safety measurements such as endometrial thickness and serum hormone levels. They are considered a safe alternative to hormonal treatments for managing symptoms like vaginal dryness.34567
How does the treatment of non-hormonal moisturizer and sexual health counseling for breast cancer differ from other treatments?
This treatment is unique because it combines a non-hormonal vaginal moisturizer, which provides temporary relief from vaginal dryness without the use of hormones, with sexual health counseling, which addresses broader sexual health concerns and improves sexual satisfaction. Unlike hormonal treatments, this approach is suitable for breast cancer survivors who may need to avoid hormones.13489
Eligibility Criteria
This trial is for premenopausal or perimenopausal women with hormone receptor positive breast cancer stages 0-III, who are starting ovarian suppression and endocrine therapy. They must be at least 18 years old and have had a menstrual period or been pregnant in the last two years, or have/had an IUD.Inclusion Criteria
I am a woman who has been pregnant or had a period in the last 2 years, or I have/had an IUD.
My breast cancer is hormone receptor positive and is stage 0 to III.
I am a woman aged 18 or older.
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Exclusion Criteria
I experience symptoms like vaginal dryness.
I am a postmenopausal woman who has not had a period for 2 years or more.
I have not started both ovarian suppression and hormone therapy.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive sexual health counseling and non-hormonal moisturizers at the start of ovarian suppression
1 year
Regular visits for monitoring and counseling
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Treatment Details
Interventions
- Non-hormonal Moisturizer (Other)
- Sexual Health Counselling (Behavioural Intervention)
Trial OverviewThe study tests if sexual health counseling and using non-hormonal moisturizers from the start of ovarian suppression can prevent or reduce vaginal dryness and sexual dysfunction compared to treating these issues after they arise. Participants will also fill out surveys about their sexual health.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: interventionExperimental Treatment2 Interventions
Patients who are randomized to the upfront arm will receive sexual health counseling and be initiated on non-hormonal moisturizers 3-5 times per week (based on data regarding need in our patient population) at the time ovarian suppression. The upfront intervention group will also be educated about dilators and have a consultation with a pelvic floor physical therapist. Some potential vaginal moisturizers include Hyalogyn, Replens, Liquibeads, or Vitamin E capsules.
Group II: standard of careActive Control2 Interventions
Standard of care arm will receive treatment at the time symptoms develop. Patients will be provided a list of recommended moisturizers by the female sexual medicine and women's health program (FSMWHP), but will purchase the moisturizers themselves at their local pharmacy.
Non-hormonal Moisturizer is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Vaginal Moisturizer for:
- Vaginal dryness
- Vulvovaginal atrophy
- Genitourinary syndrome of menopause (GSM)
🇪🇺 Approved in European Union as Vaginal Moisturizer for:
- Vaginal dryness
- Vulvovaginal atrophy
- Genitourinary syndrome of menopause (GSM)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Memorial Sloan Kettering Nassau (Limited Protocol Activities)Uniondale, NY
Memorial Sloan Kettering Cancer Center - Suffolk (Limited Protocol Activities)Commack, NY
Memorial Sloan Kettering Westchester (Limited Protocol Activities)Harrison, NY
Memorial Sloan Kettering Cancer CenterNew York, NY
More Trial Locations
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Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
References
Management of sexual dysfunction in breast cancer survivors: a systematic review. [2022]Female sexual dysfunction occurs frequently in midlife breast cancer survivors (BCS) and encompasses problems with sexual desire, interest, arousal, orgasm and genitopelvic pain. Although common, sexual problems are under-diagnosed and under-treated in BCS. The objective of this review was to assess primary studies that intervene on sexual dysfunction in BCS. In February 2015, PubMed, SCOPUS, CINAHL, COCHRANE and Web of Science databases were systematically searched for randomized controlled clinical trials (RCTs) of vaginal (lubricants, moisturizers, estrogens, dehydroepiandrosterone [DHEA], testosterone, vibrators, dilators), systemic (androgens, anti-depressants, flibanserin, ospemifene), physical therapy (physical activity, pelvic floor training), counseling and educational interventions on sexual function in BCS. Observational studies of vaginal interventions were also included due to the paucity of RCTs. The search yielded 1414 studies, 34 of which met inclusion criteria. Both interventions and outcomes, measured by 31 different sexual function scales, were heterogeneous, and therefore data were not pooled. The review found that regular and prolonged use of vaginal moisturizers was effective in improving vaginal dryness, dyspareunia, and sexual satisfaction. Educational and counseling interventions targeting sexual dysfunction showed consistent improvement in various aspects of sexual health. No consistent improvements in sexual health were observed with physical activity, transdermal testosterone or hot flash interventions. There was a lack of BCS-specific data on vaginal lubricants, vibrators, dilators, pelvic floor therapy, flibanserin or ospemifene. Overall, the quality of evidence for these studies was moderate to very low. Because each of the interventions with BCS data had limited efficacy, clinical trials to test novel interventions are needed to provide evidence-based clinical recommendations and improve sexual function in BCS.
Use of Moisturizers and Lubricants for Vulvovaginal Atrophy. [2022]The estrogen decrease in postmenopausal women results in functional and anatomical changes in the genitourinary tract. The most prevalent and bothersome symptoms are vaginal dryness, dyspareunia, and reduced lubrication, which can significantly affect the quality of life of these women, principally those who are sexually active. Hormonal therapy with local estrogens is generally considered the "gold standard." However, there are cases in which there are clinical concerns about its use or women opt for non-hormonal options. Thus, safe and effective non-hormonal options are needed to improve symptoms in these women. Moisturizers and lubricants are first-line therapy for breast cancer survivors.
Low-dose vaginal estrogens or vaginal moisturizer in breast cancer survivors with urogenital atrophy: a preliminary study. [2016]The study aim is to evaluate the efficacy and safety of two low-dose vaginal estrogen treatments (ETs) and of a non-hormonal vaginal moisturizer in postmenopausal breast cancer survivors with urogenital atrophy. Eighteen patients receiving estriol cream 0.25 mg (n = 10) or estradiol tablets 12.5 microg (n = 8) twice/week for 12 weeks were evaluated and compared with eight patients treated with polycarbophil-based moisturizer 2.5 g twice/week. Severity of vaginal atrophy was assessed using subjective [Vaginal Symptoms Score (VSS), Profile of Female Sexual Function (PFSF)] and objective [Vaginal Health Index (VHI), Karyopycnotic Index (KI)] evaluations, while safety by measuring endometrial thickness and serum sex hormones levels. After 4 weeks, VSS and VHI were significantly improved by both vaginal ETs, with further improvement after 12 weeks. PFSF improved significantly only in estriol group (p = 0.02). Safety measurements did not significantly change. Vaginal moisturizer improved VSS at week 4 (p = 0.01), but score returned to pre-treatment values at week 12; no significant modification of VHI, KI, PFSF was recorded. Both low-dose vaginal ET are effective for relieving urogenital atrophy, while non-hormonal moisturizer only provides transient benefit. The increase of serum estrogens levels during treatment with vaginal estrogen at these dosages is minimal.
Non-hormonal topical treatment of vulvovaginal atrophy: an up-to-date overview. [2018]Vulvovaginal atrophy-related symptoms exert a negative impact on the quality of life of up to 50% of postmenopausal women. Many of them decline to use topical vaginal estrogen, which is the standard effective therapy, due to the adverse publicity over recent years, and seek for alternatives. Further, there are no safety studies to support the use of topical vaginal estrogen in breast cancer survivors, and it is considered as contraindicated by many health-care professionals. Vaginal moisturizers and lubricants as well as regular sexual activity may be helpful to such women. Vaginal moisturizers may have an equivalent efficacy to topical vaginal estrogen and should be offered to women wishing to avoid the use of hormonal therapy. Lubricants are usually used during sexual intercourse to provide temporary relief from vaginal dryness and dyspareunia; however, they have no long-term therapeutic effects. We provide in this systematic review up-to-date information, for women and health-care professionals, about the use, safety and efficacy of the available vaginal moisturizers and lubricants.
Efficacy and safety of a non-hormonal intravaginal moisturizer for the treatment of vaginal dryness in postmenopausal women with sexual dysfunction. [2019]Evaluate the efficacy and safety of a non-hormonal intravaginal moisturizer on reducing the symptoms arising from vaginal dryness and sexual dysfunction.
Comparative study: Replens versus local estrogen in menopausal women. [2022]This was an open-label study comparing effects of a nonhormonal drug-free bioadhesive vaginal moisturizer to a local estrogen therapy in the treatment of vaginal dryness symptoms. There were 15 women evaluated in each treatment group during a 12-week period. Results indicated that the bioadhesive vaginal moisturizer was a safe and effective alternative to estrogen vaginal cream, with both therapies exhibiting statistically significant increases in vaginal moisture, vaginal fluid volume, and vaginal elasticity with a return of the premenopausal pH state.
Vaginal hormone-free moisturising cream is not inferior to an estriol cream for treating symptoms of vulvovaginal atrophy: Prospective, randomised study. [2022]This prospective, open-label, multicentre, multinational, randomised trial investigated the non-inferiority of treatment with a vaginal hormone-free moisturising cream compared to a vaginal estriol (0.1%) cream in a panel of post-menopausal women suffering from symptoms of vulvovaginal dryness in a parallel group design. In total, 172 post-menopausal women were randomly allocated to either one of the two treatments, each administered for 43 days. The primary endpoint was the total severity score of subjective symptoms (dryness, itching, burning and pain unrelated to sexual intercourse) of the respective treatment period. Secondary endpoints were severity of single subjective symptoms (including dyspareunia if sexually active), impairment of daily life, Vaginal Health Index, as well as assessment of safety. In both groups, women treated with hormone-free moisturising cream and those treated with estriol cream, total severity score improved significantly compared to baseline by 5.0 (from 6.1 to 1.1) and by 5.4 (from 6.0 to 0.6), respectively, after 43 days of treatment (p
Vaginal Dryness and Beyond: The Sexual Health Needs of Women Diagnosed With Metastatic Breast Cancer. [2016]While research on the sexual health of women with early stage cancer has grown extensively over the past decade, markedly less information is available to support the sexual health needs of women diagnosed with advanced breast cancer. Semistructured interviews were conducted with 32 women diagnosed with metastatic breast cancer (ages 35 to 77) about questions they had concerning their sexual health and intimate relationships. All participants were recruited from a comprehensive cancer center at a large Midwestern university. Three themes were examined: the role of sexual activity and intimate touch in participants' lives, unmet information needs about sexual health, and communication with medical providers about sexual concerns. Findings indicated that sexual activities with partners were important; however, participants worried about their own physical limitations and reported frequent physical (e.g., bone pains) and vaginal pain associated with intercourse. When women raised concerns about these issues in clinical settings, medical providers often focused exclusively on vaginal lubricants, which did not address the entirety of women's problems or concerns. In addition, women diagnosed with metastatic breast cancer reported needing additional resources about specialized vaginal lubricants, nonpenetrative and nongenitally focused sex, and sexual positions that did not compromise their physical health yet still provided pleasure.
How to Address Sexual Problems in Female Cancer Patients. [2018]Sexual health is an important aspect of human life, and cancer does not (and should not) change that. Data suggest that issues related to sexual function are quite common among women treated for cancer. However, clinicians often spend little to no time on the topic. This article provides a concise summary on the importance of sexual health among women treated for cancer, as well as an approach that general cancer clinicians can adopt in order to normalize sexual health issues for their patients. Finally, we provide an overview of sexual health therapeutics available in the United States and in Europe.