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

Trial Summary

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. ^{1 2 3 4 5}

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. ^{3 4 5 6 7}

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. ^{1 3 4 8 9}

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.

Research Team

Shari Goldfarb, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

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.

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

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
• 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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Management of sexual dysfunction in breast cancer survivors: a systematic review. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Use of Moisturizers and Lubricants for Vulvovaginal Atrophy. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Low-dose vaginal estrogens or vaginal moisturizer in breast cancer survivors with urogenital atrophy: a preliminary study. [2016]

4. England pubmed.ncbi.nlm.nih.gov

Non-hormonal topical treatment of vulvovaginal atrophy: an up-to-date overview. [2018]

5. Ireland 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. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

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

7. United States 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. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Vaginal Dryness and Beyond: The Sexual Health Needs of Women Diagnosed With Metastatic Breast Cancer. [2016]

9. United States pubmed.ncbi.nlm.nih.gov

How to Address Sexual Problems in Female Cancer Patients. [2018]