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

Primary Purpose

Vaginal Atrophy, Genitourinary System; Disorder, Female, Vaginal Abnormality

Status

Suspended

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Viveve®

About this trial

This is an interventional treatment trial for Vaginal Atrophy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Marina Plastic Surgery Associates

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Viveve treatment

Arm Description

Group of women who receive Viveve treatment

Outcomes

Primary Outcome Measures

Sexual dysfunction

Measurement of changes in sexual dysfunction using the Female Sexual Function Index (FSFI)

Secondary Outcome Measures

Sexual distress

Measurement of changes in sexual distress using the Female Sexual Distress Scale-Revised (FSDS-R)

Vaginal symptoms

Measurement of changes in vaginal symptoms using the Day-to-Day Impact of Vaginal Aging (DIVA) Questionnaire

Vaginal laxity

Measurement of changes in vaginal laxity using the Vaginal Laxity Questionnaire (VLQ)

Full Information

NCT ID

NCT03547089

First Posted

May 24, 2018

Last Updated

March 13, 2019

Sponsor

W. Grant Stevens, MD

1. Study Identification

Unique Protocol Identification Number

NCT03547089

Brief Title

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

Acronym

BRAVO

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Suspended

Why Stopped

Recruitment issues

Study Start Date

August 1, 2018 (Actual)

Primary Completion Date

March 1, 2020 (Anticipated)

Study Completion Date

March 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

W. Grant Stevens, MD

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Viveve treatment

Arm Type

Experimental

Arm Description

Group of women who receive Viveve treatment

Intervention Type

Device

Intervention Name(s)

Viveve®

Intervention Description

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

Primary Outcome Measure Information:

Title

Sexual dysfunction

Description

Measurement of changes in sexual dysfunction using the Female Sexual Function Index (FSFI)

Time Frame

Baseline, 1 month, 3 months, 6 months

Secondary Outcome Measure Information:

Title

Sexual distress

Description

Measurement of changes in sexual distress using the Female Sexual Distress Scale-Revised (FSDS-R)

Time Frame

Baseline, 1 month, 3 months, 6 months

Title

Vaginal symptoms

Description

Measurement of changes in vaginal symptoms using the Day-to-Day Impact of Vaginal Aging (DIVA) Questionnaire

Time Frame

Baseline, 1 month, 3 months, 6 months

Title

Vaginal laxity

Description

Measurement of changes in vaginal laxity using the Vaginal Laxity Questionnaire (VLQ)

Time Frame

Baseline, 1 month, 3 months, 6 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

W G Stevens, MD

Organizational Affiliation

Marina Plastic Surgery

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Ali A Qureshi, MD

Organizational Affiliation

Marina Plastic Surgery

Official's Role

Study Director

Facility Information:

Facility Name

Marina Plastic Surgery Associates

City

Marina Del Rey

State/Province

California

ZIP/Postal Code

90292

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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