A Study to Prevent and Improve Sexual Health Concerns for People With Breast Cancer
Recruiting · NCT05910294 · Interventional (participants receive a specific treatment) · Lead sponsor: Memorial Sloan Kettering Cancer Center
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
Where it is running
7 locations listed across 2 US states.
- 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