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A Study to Prevent and Improve Sexual Health Concerns for People With Breast Cancer
Trial Status: active
This clinical trial evaluates whether sexual health counseling and vaginal moisturizer use at the start of ovarian suppression therapy works to reduce side effects such as vaginal dryness and sexual dysfunction in patients with stage 0-III hormone receptor-positive breast cancer. Breast cancer is the most common malignancy among premenopausal women in the United States. Research has shown that premenopausal women receiving ovarian suppression as part of their breast cancer treatment have improved disease free and overall survival. However, ovarian suppression in combination with endocrine therapy can cause side effects including sexual dysfunction, decreased arousal, decreased libido, and decreased sexual satisfaction. Currently, the usual approach is to treat these symptoms at the time they develop. Sexual health counseling and vaginal moisturizer use at the start of ovarian suppression, before symptoms have started, may be effective at preventing or reducing side effects of treatment.
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 intrauterine device (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 vulvovaginal atrophy (VVA) treatment (e.g. intravaginal estrogen, other non-hormonal moisturizer or suppository), unless discontinued with washout of 4 weeks
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05910294.
I. To evaluate if a prevention intervention in comparison to a symptom-triggered intervention prevents vaginal dryness and sexual health concerns in premenopausal or perimenopausal women treated with ovarian suppression as measured by Vaginal Assessment Scale (VAS) throughout the study.
SECONDARY OBJECTIVES:
I. To compare the prevention intervention and the symptom-triggered intervention in preventing vaginal dryness and sexual health concerns in premenopausal or perimenopausal women treated with ovarian suppression as measured by VAS throughout the study.
II. To evaluate sexual health concerns in women treated with ovarian suppression and endocrine therapy for breast cancer as reported on the Breast Clinical Care and Symptom Survey (BCCSS) and based on pelvic exams and Patient Reported Outcomes (PROs) including Female Sexual Function Index (FSFI), Female Sexual Distress Scale Revised (FSDS-R), Menopausal Symptom Check List (MSCL), and Patient-reported Outcomes Measurement Information System Sexual Function Instrument (PROMIS-SF).
III. To evaluate changes in VAS and Vulvar Assessment Scale (VuAS) throughout the study.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM 1: Patients receive education on the sexual and vulvovaginal side effects of ovarian suppression and begin applying vaginal moisturizer topically 3-5 times weekly at the start of ovarian suppression therapy up to 6 months. Patients also receive education on dilators and have a consultation with a pelvic floor physical therapist. Patients undergo a pelvic exam at 1 week, 3 months, 6 months, and at the time of symptom onset/worsening.
ARM 2: Patients receive standard of care endocrine therapy education before beginning ovarian suppression therapy. After beginning ovarian suppression therapy, at the time of symptom onset, patients receive education on the sexual and vulvovaginal side effects of ovarian suppression and dilators and begin applying vaginal moisturizers topically. Patients also receive a referral to a pelvic floor physical therapist. Patients undergo a pelvic exam at 1 week, 6 months, and at the time of symptom onset.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationMemorial Sloan Kettering Cancer Center
