Sexual Health Support for Breast Cancer

Recruiting at 6 trial locations

Overseen By Jeanne Carter, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Must be taking: Ovarian suppression, Endocrine therapy

Disqualifiers: Postmenopausal, High urogenital symptoms

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 year

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether early sexual health support can prevent or reduce issues like vaginal dryness and sexual dysfunction in women with breast cancer undergoing ovarian suppression treatment. The study compares early intervention using sexual health counseling and non-hormonal vaginal moisturizers to the usual approach of treating symptoms after they appear. Women with hormone receptor-positive breast cancer who have not yet experienced vaginal symptoms may be suitable candidates for this trial. Participants will complete surveys about their sexual health, aiding researchers in understanding these side effects. As an unphased trial, this study offers participants the chance to contribute to important research that could enhance sexual health support for women with breast cancer.

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 prior data suggests that sexual health counselling and non-hormonal moisturizers are safe for women with breast cancer?

Research has shown that non-hormonal moisturizers are generally safe for improving vaginal health. One study found these moisturizers effectively reduce vaginal dryness without major safety concerns. Because they lack hormones, they are a suitable option for breast cancer survivors.

Research indicates that sexual health counseling can enhance sexual well-being for cancer survivors. This method involves discussing sexual health issues, which helps improve quality of life. Counseling poses no known safety risks.

Overall, existing research considers both treatments—non-hormonal moisturizers and sexual health counseling—safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the treatments in this trial because they focus on non-hormonal solutions for sexual health issues in breast cancer patients, which is crucial for those who can't use hormone-based therapies. The non-hormonal moisturizer offers a safer option with potential moisturizing agents like Hyalogyn, Replens, or Vitamin E capsules, which can be used multiple times a week to alleviate symptoms without hormone-related side effects. Additionally, the inclusion of sexual health counseling and pelvic floor therapy provides a holistic approach, addressing not just physical symptoms but also emotional and psychological well-being, which is often overlooked in traditional treatments.

What evidence suggests that this trial's treatments could be effective for preventing or reducing sexual dysfunction in women with breast cancer?

Research has shown that non-hormonal moisturizers, which participants in this trial may use, can help manage vaginal dryness for breast cancer survivors. These moisturizers often relieve dryness more effectively than regular lubricants. They maintain moisture in the vaginal area and can be used regularly without the risks associated with hormones.

In this trial, some participants will receive sexual health counseling, which evidence indicates can be very beneficial for breast cancer survivors. According to a study, counseling helps reduce sexual distress and improve body image. Non-drug methods, like counseling, have been linked to better sexual health outcomes. Together, these approaches aim to support the sexual health of women undergoing ovarian suppression. ^{1 2 3 5 6}

Who Is on the Research Team?

Shari Goldfarb, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Non-hormonal Moisturizer
• Sexual Health Counselling

Trial Overview The 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.

How Is the Trial Designed?

Group I: intervention Experimental Treatment 2 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: symptom onset Active Control 2 Interventions

Symptom onset 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)

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Published Research Related to This Trial

In a 12-week study involving 30 women, a nonhormonal bioadhesive vaginal moisturizer was found to be a safe and effective alternative to local estrogen therapy for treating vaginal dryness.

Both treatments significantly improved vaginal moisture, fluid volume, and elasticity, restoring the vaginal pH to premenopausal levels, indicating their efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative study: Replens versus local estrogen in menopausal women. Nachtigall, LE.[2022]

In a study of 172 post-menopausal women, a hormone-free vaginal moisturising cream was found to be non-inferior to a vaginal estriol (0.1%) cream in alleviating symptoms of vulvovaginal dryness after 43 days of treatment, with significant improvements in both groups.

Both treatments effectively reduced symptoms like dryness and dyspareunia, but women with severe impairment from vaginal dryness experienced greater benefits from the estriol cream, while the hormone-free cream is recommended as a first choice for those with mild to moderate symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vaginal hormone-free moisturising cream is not inferior to an estriol cream for treating symptoms of vulvovaginal atrophy: Prospective, randomised study. Garcia de Arriba, S., Grüntkemeier, L., Häuser, M., et al.[2022]

Sexual health is a crucial aspect of life for women, and cancer treatment can significantly impact sexual function, yet clinicians often neglect to address these issues during care.

The article emphasizes the need for cancer clinicians to normalize discussions about sexual health and provides an overview of available sexual health therapeutics in the U.S. and Europe to support affected patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How to Address Sexual Problems in Female Cancer Patients. Preti, EP., Landoni, F., Colombo, N., et al.[2018]

Both low-dose vaginal estrogen treatments (estriol cream and estradiol tablets) significantly improved symptoms of urogenital atrophy in postmenopausal breast cancer survivors over 12 weeks, with effects measured by subjective and objective assessments.

The non-hormonal vaginal moisturizer provided only a temporary improvement in symptoms, highlighting that while both estrogen treatments are effective, the moisturizer's benefits do not last beyond the initial weeks of treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-dose vaginal estrogens or vaginal moisturizer in breast cancer survivors with urogenital atrophy: a preliminary study. Biglia, N., Peano, E., Sgandurra, P., et al.[2016]

Up to 50% of postmenopausal women experience vulvovaginal atrophy-related symptoms, negatively affecting their quality of life, and many avoid standard topical vaginal estrogen due to safety concerns, especially breast cancer survivors.

Vaginal moisturizers may offer similar efficacy to topical vaginal estrogen and should be considered as a safe alternative for women seeking non-hormonal treatments, while lubricants provide temporary relief but lack long-term benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-hormonal topical treatment of vulvovaginal atrophy: an up-to-date overview. Sinha, A., Ewies, AA.[2018]

Regular and prolonged use of vaginal moisturizers significantly improves vaginal dryness, dyspareunia (pain during intercourse), and overall sexual satisfaction in midlife breast cancer survivors, based on a review of 34 studies.

Educational and counseling interventions consistently enhance various aspects of sexual health in breast cancer survivors, highlighting the importance of addressing sexual dysfunction, although the overall quality of evidence remains moderate to very low.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of sexual dysfunction in breast cancer survivors: a systematic review. Seav, SM., Dominick, SA., Stepanyuk, B., et al.[2022]

Postmenopausal women often experience bothersome symptoms like vaginal dryness and pain during intercourse due to decreased estrogen levels, which can significantly impact their quality of life.

While local estrogen therapy is the gold standard for treatment, safe and effective non-hormonal options, such as moisturizers and lubricants, are recommended, especially for women who have concerns about hormone use or are breast cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Moisturizers and Lubricants for Vulvovaginal Atrophy. Sarmento, ACA., Kamilos, MF., Costa, APF., et al.[2022]

In a study of 37 postmenopausal women over 12 weeks, a non-hormonal intravaginal moisturizer significantly improved vaginal moisture, elasticity, and epithelial integrity, indicating its efficacy in treating vaginal dryness (p < 0.001).

The moisturizer also enhanced sexual function across all measured domains, with over 50% of participants reporting high satisfaction with the treatment and no severe adverse events noted, highlighting its safety and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of a non-hormonal intravaginal moisturizer for the treatment of vaginal dryness in postmenopausal women with sexual dysfunction. Vale, F., Rezende, C., Raciclan, A., et al.[2019]

Women with metastatic breast cancer expressed a strong need for information and resources regarding their sexual health, highlighting the importance of sexual activity and intimacy despite physical limitations and pain.

Medical providers often inadequately addressed women's sexual health concerns, focusing mainly on vaginal lubricants, which did not encompass the broader range of issues faced by these women, such as pain during intercourse and the need for alternative sexual practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vaginal Dryness and Beyond: The Sexual Health Needs of Women Diagnosed With Metastatic Breast Cancer. McClelland, SI., Holland, KJ., Griggs, JJ.[2016]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6345451/

Topical treatment of vaginal dryness with a non-hormonal ... The beneficial effect of a non-hormonal moisturizing cream regarding urinary incontinence has not been reported in breast cancer patients ...

2. ajog.org ajog.org/article/S0002-9378(24)01126-8/fulltext

Vaginal estrogen use in breast cancer survivors The use of vaginal estrogen in patients with a history of breast cancer does not appear to be associated with an increased risk of breast cancer recurrence.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12254641/

Vaginal health in breast cancer survivors: a practical clinical ... Data demonstrate that polycarbophil-based non-hormonal moisturizers are superior to lubricants in temporarily mitigating vaginal dryness and ...

4. gynecologiconcology-online.net gynecologiconcology-online.net/article/S0090-8258(19)30883-2/fulltext

A single-arm clinical trial investigating the effectiveness of ... A single-arm clinical trial investigating the effectiveness of a non-hormonal vaginal moisturizer in postmenopausal cancer survivors. J. Carter. J. Carter.

5. acog.org acog.org/clinical/clinical-guidance/clinical-consensus/articles/2021/12/treatment-of-urogenital-symptoms-in-individuals-with-a-history-of-estrogen-dependent-breast-cancer

Treatment of Urogenital Symptoms in Individuals With a ... This document has been updated to review the safety and efficacy of newer hormonal treatment options as well as nonhormonal modalities.

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0301211519300302

Efficacy and safety of a non-hormonal intravaginal ... Our study suggests that treatment with the non-hormonal intravaginal moisturizer is a safe and efficient therapeutic option for the improvement of vaginal ...