Preventing sexual health issues in women with breast cancer
Randomized Pilot Prevention Trial to Improve Sexual and Vulvovaginal Health Concerns in Premenopausal Female Breast Cancer Patients Receiving Ovarian Suppression
This study is testing if early sexual health counseling and non-hormonal moisturizers can help premenopausal or perimenopausal women with breast cancer avoid sexual health problems.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Locations | 7 sites (Basking Ridge, New Jersey and 6 other locations) |
| Trial ID | NCT05910294 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of sexual health counseling and the use of non-hormonal moisturizers at the onset of ovarian suppression in premenopausal or perimenopausal women with breast cancer. Participants will be randomized to receive either the intervention upfront or the standard care approach, which treats symptoms after they develop. The study will monitor both subjective and objective measures of vaginal dryness and sexual dysfunction, alongside surveys to gather comprehensive data on sexual health. The goal is to determine if proactive measures can improve sexual health outcomes for these patients.
Who should consider this trial
Good fit: Ideal candidates are premenopausal or perimenopausal women with hormone receptor positive breast cancer who are starting ovarian suppression and are currently asymptomatic for vaginal symptoms.
Not a fit: Patients who are postmenopausal or those already experiencing significant vaginal symptoms may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance the sexual health and quality of life for women undergoing breast cancer treatment.
How similar studies have performed: While similar approaches have been explored, this specific intervention for preventing sexual health concerns in breast cancer patients undergoing ovarian suppression is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women, 18 years of age or older * Breast cancer patients with hormone receptor positive breast cancer , stage 0-III * Premenopausal or perimenopausal women who have either been pregnant or had at least one menstrual period in the last 24 months or have/had an IUD in place * Patients currently on or are being initiated on ovarian suppression * Patients are asymptomatic for vaginal symptoms of estrogen deprivation (i.e. vaginal dryness, dyspareunia, or discomfort \[pain with intercourse or examination\]) and score a 3 or less on the VAS and VuAS Exclusion Criteria: * Postmenopausal women who have been without a period for ≥ 2 years * Patients who score a 4 or above on the VAS and VuAS * Patients already using VVA treatment (e.g. intravaginal estrogen, other non-hormonal moisturizer or suppository), unless discontinued with washout of 4 weeks
Where this trial is running
Basking Ridge, New Jersey and 6 other locations
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) — Basking Ridge, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) — Middletown, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center - Suffolk (Limited Protocol Activities) — Commack, New York, United States (Recruiting)
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison, New York, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)
- Memorial Sloan Kettering Nassau (Limited Protocol Activities) — Uniondale, New York, United States (Recruiting)
Study contacts
- Principal investigator: Shari Goldfarb, MD — Memorial Sloan Kettering Cancer Center
- Study coordinator: Shari Goldfarb, MD
- Email: goldfars@mskcc.org
- Phone: 646-888-5080
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.