Clinical trial NCT03547089: A Prospective Trial to Assess Breast Cancer Survivors and Vaginal Atrophy Treatment Outcomes
Official title: A Prospective Trial to Assess Breast Cancer Survivors and Vaginal Atrophy Treatment
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Vaginal Atrophy
Genitourinary System; Disorder, Female
Vaginal Abnormality
Sexual Dysfunction
Sexual Problem
Lead sponsor: Marina Plastic Surgery
Sponsor class: OTHER
First posted: 2018-06-06
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Sexual dysfunction
timeFrame: Baseline, 1 month, 3 months, 6 months
Secondary outcomes:
measure: Sexual distress
timeFrame: Baseline, 1 month, 3 months, 6 months
measure: Vaginal symptoms
timeFrame: Baseline, 1 month, 3 months, 6 months
measure: Vaginal laxity
timeFrame: Baseline, 1 month, 3 months, 6 months
Other outcomes:
Locations:
city: Marina Del Rey
country: United States
facility: Marina Plastic Surgery Associates
state: California
Study officials:
affiliation: Marina Plastic Surgery
name: W G Stevens, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Marina Plastic Surgery
name: Ali A Qureshi, MD
role: STUDY_DIRECTOR
References: