A Prospective Trial to Assess Breast Cancer Survivors and Vaginal Atrophy Treatment Outcomes (BRAVO)

W. Grant Stevens, MD

Status: Suspended

Conditions: Sexual Problem; Vaginal Atrophy; Sexual Dysfunction; Genitourinary System; Disorder, Female; Vaginal Abnormality

Treatments: Device: Viveve®

Study type: Interventional

Funder types: Other

Identifiers

NCT03547089

VI-ISRP-026

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 10 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Exclusion Criteria:

• Cognitive impairment
• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Viveve treatment

Experimental group

Description:

Group of women who receive Viveve treatment

Treatment:

Device: Viveve®