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

Memorial Sloan Kettering Cancer Center (MSK)

Status: Enrolling

Conditions: Improve Sexual Health; Improve Vulvovaginal Health

Treatments: Other: moisturizers; Other: questionnaires

Study type: Interventional

Funder types: Other

Identifiers

NCT05910294

23-109

Details and patient eligibility

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.

Full 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.

Enrollment: 50 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

symptom onset

Active Comparator group

Description:

Symptom onset arm will receive treatment at the time symptoms develop. 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.

Treatment:

Other: questionnaires

Other: moisturizers

Other: moisturizers

intervention

Experimental group

Description:

Patients who are randomized to the upfront arm will receive sexual health counseling and be initiated on non-hormonal moisturizers 3-5 times per week (based on data regarding need in our patient population) at the time ovarian suppression. The upfront intervention group will also be educated about dilators and have a consultation with a pelvic floor physical therapist. Some potential vaginal moisturizers include Hyalogyn, Replens, Liquibeads, or Vitamin E capsules.

Treatment:

Other: questionnaires

Other: moisturizers

Other: moisturizers