Actively Recruiting
Randomized Pilot Trial to Prevent and Improve Sexual and Vulvovaginal Health Concerns in Premenopausal Female Breast Cancer Patients Receiving Ovarian Suppression
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-04-01
50
Participants Needed
7
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying sexual health and vulvovaginal health in premenopausal and perimenopausal women with hormone receptor positive breast cancer who are receiving ovarian suppression. The study aims to find out if starting sexual health counseling and using non-hormonal moisturizers early can prevent or reduce side effects like vaginal dryness and sexual dysfunction. This is compared to the usual care approach where treatment begins only after symptoms appear. Participants will be randomly assigned to one of two groups. One group will receive sexual health counseling and start using non-hormonal moisturizers 3 to 5 times weekly from the beginning of ovarian suppression, along with education about vaginal dilators and a consultation with a pelvic floor physical therapist. The other group will start treatment only after developing symptoms and will receive a list of recommended moisturizers to purchase themselves. Both groups will complete various questionnaires to monitor sexual health and vaginal symptoms. During the study, participants will be monitored through surveys and subjective and objective assessments of vaginal dryness and sexual function. Researchers will track the number of participants who have a score of 4 or higher on the Vaginal Assessment Scale within one year. The study includes regular completion of validated questionnaires and a weekly diary about moisturizer use. The total participation time corresponds with one year of follow-up to evaluate the intervention's impact.
CONDITIONS
Brief Title
A Study to Prevent and Improve Sexual Health Concerns for People With Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women 18 years of age or older
- Hormone receptor positive breast cancer patients, stage 0-III
- Premenopausal or perimenopausal women who have been pregnant, had a menstrual period in the last 24 months, or have/had an IUD
- Currently on or starting ovarian suppression
- Asymptomatic for vaginal symptoms of estrogen deprivation and score 3 or less on VAS and VuAS
You will not qualify if you...
- Postmenopausal women without a period for 2 or more years
- Patients scoring 4 or above on VAS and VuAS
- Currently using vaginal atrophy treatments unless stopped with a 4-week washout
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of ovarian suppression treatment
Participants are randomized to either receive upfront sexual health counseling and use non-hormonal moisturizers 3-5 times per week, along with education about dilators and a pelvic floor physical therapy consultation, or to receive treatment at symptom onset with recommended moisturizers purchased from a pharmacy.
Regular monitoring visits with questionnaires and symptom assessments
Duration - Up to 1 year after treatment initiation
Participants are monitored for sexual and vulvovaginal health concerns through subjective and objective assessments to evaluate outcomes at 1 year.
Periodic visits for assessments and questionnaires
Trial Site Locations
Total: 7 locations
1
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
2
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
3
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
4
Memorial Sloan Kettering Cancer Center - Suffolk (Limited Protocol Activities)
Commack, New York, United States, 11725
Actively Recruiting
5
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
7
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, United States, 11553
Actively Recruiting
Research Team
S
Shari Goldfarb, MD
J
Jeanne Carter, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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