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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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "All participants will also complete surveys about their sexual health."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether sexual health counseling and a hormone-free vaginal moisturizer can prevent or reduce vaginal dryness and sexual problems. It is for women with breast cancer who are starting or receiving treatment to stop their ovaries from making hormones. Researchers will compare this early care with treating problems after they start, and everyone will complete sexual health surveys.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Women age 18 or older.
  • Have stage 0–III breast cancer that uses hormones to grow.
  • Have not finished menopause and have been pregnant or had at least one period in the past 24 months, or have or had an IUD (a birth control device in the uterus).
  • Are receiving or starting treatment to stop the ovaries from making hormones.
  • Have no vaginal symptoms from low estrogen, such as dryness or pain during sex or an exam, and score 3 or less on both study symptom scales (VAS and VuAS).

Who can't join

  • Have finished menopause and have had no period for at least 2 years.
  • Score 4 or higher on both study symptom scales (VAS and VuAS).
  • Already use treatment for vaginal symptoms, such as vaginal estrogen, a hormone-free moisturizer, or medicine placed inside the vagina, unless it has been stopped for 4 weeks.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (7)

NJ

NY

  • Memorial Sloan Kettering Cancer Center - Suffolk (Limited Protocol Activities) · Commack, NY 11725Shari Goldfarb, MD · Study contactMore trials in Commack
  • Memorial Sloan Kettering Westchester (Limited Protocol Activities) · Harrison, NY 10604Shari Goldfarb, MD · Study contact · 646-888-5080More trials in Harrison
  • Memorial Sloan Kettering Cancer Center · New York, NY 10065Shari Goldfarb, MD · Study contact · 646-888-5080Jeanne Carter, PhD · Study contact · 646-888-5076Shari Goldfarb, MD · Principal investigatorMore trials in New York
  • Memorial Sloan Kettering Nassau (Limited Protocol Activities) · Uniondale, NY 11553Shari Goldfarb, MD · Study contact · 646-888-5080More trials in Uniondale