Randomized Pilot Prevention Trial to Improve Sexual and Vulvovaginal Health Concerns in Premenopausal Female Breast Cancer Patients Receiving Ovarian Suppression
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Improve Sexual Health
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Enrollment
- 50
- Locations
- 7
- Primary Endpoint
- Number of participants with a score of 4 or greater in VAS
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Investigators
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
Outcomes
Primary Outcomes
Number of participants with a score of 4 or greater in VAS
Time Frame: 1 year
measured by the Vaginal Assessment Scale (VAS)