RecruitingNot ApplicableNCT05910294

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


Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

50 participants

Start Date

Jun 1, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether an early intervention program can prevent vaginal dryness and sexual discomfort in premenopausal women with hormone receptor-positive breast cancer who are starting ovarian suppression therapy — a treatment that causes menopausal-like symptoms. **You may be eligible if...** - You are a woman aged 18 or older with hormone receptor-positive breast cancer (stage 0–III) - You are premenopausal or perimenopausal - You are starting or already on ovarian suppression therapy - You currently do NOT have significant vaginal dryness or pain with intercourse (score 3 or lower) **You may NOT be eligible if...** - You are postmenopausal (no period for 2 or more years) - You already have significant vaginal symptoms (score 4 or above on the symptom scale) - You are already using a vaginal estrogen product, moisturizer, or suppository (unless you stop and wait 4 weeks) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERquestionnaires

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

OTHERmoisturizers

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.

OTHERmoisturizers

potential vaginal moisturizers include Hyalogyn, Replens, Liquibeads, or Vitamin E capsules


Locations(7)

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, United States

Memorial Sloan Kettering Cancer Center - Suffolk (Limited Protocol Activities)

Commack, New York, United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, United States

View Full Details on ClinicalTrials.gov

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NCT05910294