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Recruiting NCT05910294

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

No phase Interventional Improve Sexual Health Improve Vulvovaginal Health

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: questionnaires, moisturizers, moisturizers.
Who it may be relevant to
Registry conditions: Improve Sexual Health, Improve Vulvovaginal Health. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Randomized Pilot Prevention Trial to Improve Sexual and Vulvovaginal Health Concerns in Premenopausal Female Breast Cancer Patients Receiving Ovarian Suppression

Overview

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.

Detailed description

50 premenopausal or perimenopausal women who are receiving ovarian suppression as part of their breast cancer treatment will be randomized to upfront intervention vs at the time of symptom development (standard of care). Patients will have subjective and objective monitoring of vaginal dryness and sexual dysfunction.

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 outcome measures

  • Number of participants with a score of 4 or greater in VAS [Time frame: 1 year]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 7 centers
  • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) — Basking Ridge
  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities) — Middletown
  • Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale
  • Memorial Sloan Kettering Cancer Center - Suffolk (Limited Protocol Activities) — Commack
  • Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison
  • Memorial Sloan Kettering Cancer Center — New York
  • Memorial Sloan Kettering Nassau (Limited Protocol Activities) — Uniondale

Identifiers

NCT: NCT05910294 · 23-109

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗