What this study is
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.
What's being tested
- questionnaires
Intervention · OTHER
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
- moisturizers
Intervention · OTHER
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.
- moisturizers
Intervention · OTHER
potential vaginal moisturizers include Hyalogyn, Replens, Liquibeads, or Vitamin E capsules
Study details
- Official title
- 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
- Conditions
- Improve Sexual Health · Improve Vulvovaginal Health
- Enrolling
- 50 people
- Starts
- 2023-06-01
- Est. completion
- 2027-06
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex FEMALEHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (7)
7 openContact for 6 of 7 open sites
- Shari Goldfarb, MD · Contact646-888-5080
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States
RecruitingMemorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States
RecruitingMemorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States
RecruitingMemorial Sloan Kettering Cancer Center - Suffolk (Limited Protocol Activities)
Commack, New York, United States
- Shari Goldfarb, MD · Contact
RecruitingMemorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States
RecruitingMemorial Sloan Kettering Cancer Center
New York, New York, United States
- Jeanne Carter, PhD · Contact646-888-5076
- Shari Goldfarb, MD · Principal investigator
RecruitingMemorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, United States
Recruiting
Study team
Sponsor
Memorial Sloan Kettering Cancer Center
Study ID 23-109
Principal investigator
Shari Goldfarb, MD
Memorial Sloan Kettering Cancer Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.