Breast Cancer Clinical Trial
A Prospective Trial to Assess Breast Cancer Survivors and Vaginal Atrophy Treatment Outcomes
The focus of this study is to assess breast cancer survivors perspectives of Viveve® Treatment using patient reported outcome tools with a focus on symptoms associated with vulvovaginal atrophy/genitourinary syndrome of menopause (GSM). This will be assessed by the FSFI, FSDS-R and DIVA questionnaires.
Breast cancers that are hormone sensitive require estrogen suppression as a part of multimodal treatment. Estrogen suppression also reduces the likelihood of a breast cancer recurrence. Therefore, breast cancer survivors with estrogen sensitive tumors are placed on hormone suppression therapy with either selective estrogen receptor modulators like tamoxifen or aromatase inhibitors like anastrazole. This therapy typically is administered for five years after a cancer diagnosis. Regardless of age or pre-existing menopausal status, the hormone suppression reduces estrogen levels and can either exacerbate existing menopausal symptoms or induce medical menopause in otherwise premenopausal women. This study will evaluate the patient's perspective of vaginal therapy using the Viveve® device in breast cancer patients.
Key Inclusion Criteria:
18 years or older
Breast cancer survivors defined as women with a history of hormone sensitive breast cancer on tamoxifen
Self-reported vaginal laxity
Meet diagnosis of sexual dysfunction
Patients must be able to understand and willing to sign a written informed consent document and be willing to complete the patient reported outcome tools at the scheduled time points
Women currently on chemotherapy and/or radiation or who have had their last chemotherapy within 6 months of the intervention
Women with active breast cancer disease
Women currently on hormone therapy or who are pregnant
Women who have had vaginal or pelvic surgery involving the genitalia
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There is 1 Location for this study
Marina Del Rey California, 90292, United States
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