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

Sexual Dysfunction Clinical Trial

— BRAVO  

Official title:

A Prospective Trial to Assess Breast Cancer Survivors and Vaginal Atrophy Treatment

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03547089
• Other study ID #: VI-ISRP-026
• Status: Suspended
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: March 1, 2020

Study information

• Verified date: March 2019
• Source: Marina Plastic Surgery
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 10
• Est. completion date: March 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• Viveve®
A single treatment using Viveve® with 110 pulses administered to the vaginal introitus at 90 J/cm2

Locations

Country	Name	City	State
United States	Marina Plastic Surgery Associates	Marina Del Rey	California

Sponsors (1)

Lead Sponsor	Collaborator
W. Grant Stevens, MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sexual dysfunction	Measurement of changes in sexual dysfunction using the Female Sexual Function Index (FSFI)	Baseline, 1 month, 3 months, 6 months
Secondary	Sexual distress	Measurement of changes in sexual distress using the Female Sexual Distress Scale-Revised (FSDS-R)	Baseline, 1 month, 3 months, 6 months
Secondary	Vaginal symptoms	Measurement of changes in vaginal symptoms using the Day-to-Day Impact of Vaginal Aging (DIVA) Questionnaire	Baseline, 1 month, 3 months, 6 months
Secondary	Vaginal laxity	Measurement of changes in vaginal laxity using the Vaginal Laxity Questionnaire (VLQ)	Baseline, 1 month, 3 months, 6 months