NCT05910294

A Study to Prevent and Improve Sexual Health Concerns for People With Breast Cancer

Randomized Pilot Prevention Trial to Improve Sexual and Vulvovaginal Health Concerns in Premenopausal Female Breast Cancer Patients Receiving Ovarian Suppression

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

50 premenopausal or perimenopausal women who are receiving ovarian suppression as part of their breast cancer treatment will be randomized to upfront intervention vs at the time of symptom development (standard of care). Patients will have subjective and objective monitoring of vaginal dryness and sexual dysfunction.

Conditions

• Improve Sexual Health
• Improve Vulvovaginal Health

Interventions

Type	Name	Description
OTHER	questionnaires	Vaginal Assessment Scale (VAS) \& Vulvar Assessment Scale (VuAS) Breast Clinical Care and Symptom Survey (BCCSS) Female Sexual Function Index (FSFI) Sexual Activity Questionnaire (SAQ) Female Sexual Distress Scale Revised (FSDS-R) Menopausal Symptom Check List (MSCL) Patient-reported Outcomes Measurement Information System Sexual Function Instrument (PROMIS-SF) Weekly Non-Hormonal Moisturizer Diary
OTHER	moisturizers	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.
OTHER	moisturizers	potential vaginal moisturizers include Hyalogyn, Replens, Liquibeads, or Vitamin E capsules

Timeline

• Start date: 2023-06-01
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2023-06-18
• Last updated: 2026-04-01

Locations

7 sites across 1 country: United States