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

Not Applicable

Suspended

• Conditions: Sexual Dysfunction; Vaginal Atrophy; Genitourinary System; Disorder, Female; Vaginal Abnormality; Sexual Problem
• Interventions: Device: Viveve®

• Registration Number: NCT03547089
• Lead Sponsor: W. Grant Stevens, MD

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.

Study Timeline

• Study First Submitted: 2018-05-24
• Study First Submitted QC: 2018-06-05
• Study First Posted: 2018-06-06
• Study Start: 2018-08-01
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-13
• Last Update Posted: 2019-03-15
• Primary Completion: 2020-03-01
• Study Completion: 2020-03-01

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: Female
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Viveve treatment	Viveve®	Group of women who receive Viveve treatment

Primary Outcome Measures

Name	Time	Method
Sexual dysfunction	Baseline, 1 month, 3 months, 6 months	Measurement of changes in sexual dysfunction using the Female Sexual Function Index (FSFI)

Secondary Outcome Measures

Name	Time	Method
Sexual distress	Baseline, 1 month, 3 months, 6 months	Measurement of changes in sexual distress using the Female Sexual Distress Scale-Revised (FSDS-R)
Vaginal symptoms	Baseline, 1 month, 3 months, 6 months	Measurement of changes in vaginal symptoms using the Day-to-Day Impact of Vaginal Aging (DIVA) Questionnaire
Vaginal laxity	Baseline, 1 month, 3 months, 6 months	Measurement of changes in vaginal laxity using the Vaginal Laxity Questionnaire (VLQ)

Trial Locations

Locations (1)

Marina Plastic Surgery Associates; 🇺🇸 Marina Del Rey, California, United States