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

NCT ID: NCT03547089

Last Updated: 2019-03-15

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-01
• Study Completion Date: 2020-03-01

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Viveve treatment

Group of women who receive Viveve treatment

Group Type: EXPERIMENTAL

Viveve®

Intervention Type: DEVICE

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

Interventions

Viveve®

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

W. Grant Stevens, MD

OTHER

Sponsor Role: lead

Responsible Party

W. Grant Stevens, MD

Director

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

W G Stevens, MD

Role: PRINCIPAL_INVESTIGATOR

Marina Plastic Surgery

Ali A Qureshi, MD

Role: STUDY_DIRECTOR

Marina Plastic Surgery

Locations

Marina Plastic Surgery Associates

Marina del Rey, California, United States

Countries

United States

Other Identifiers

VI-ISRP-026

Identifier Type: -

Identifier Source: org_study_id