Recruiting

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

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…

ClinicalTrials.gov IDNCT05910294

PhaseNA

Enrollment50

SponsorMemorial Sloan Kettering Cancer Center

Age18 Years

SexFEMALE

I'm interested View official listing

Conditions studied

Improve Sexual Health, Improve Vulvovaginal Health

About this study

Interventions

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

Primary outcomes

Number of participants with a score of 4 or greater in VAS (1 year)

Eligibility information

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

Study locations

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey 07920 United States
Memorial Sloan Kettering Monmouth (Limited Protocol Activities), Middletown, New Jersey 07748 United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale, New Jersey 07645 United States
Memorial Sloan Kettering Cancer Center - Suffolk (Limited Protocol Activities), Commack, New York 11725 United States
Memorial Sloan Kettering Westchester (Limited Protocol Activities), Harrison, New York 10604 United States
Memorial Sloan Kettering Cancer Center, New York, New York 10065 United States
Memorial Sloan Kettering Nassau (Limited Protocol Activities), Uniondale, New York 11553 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.