Alterations in the Vaginal Microenvironment Using a Non-pharmacological Intervention

Phase 2

Terminated

Conditions: Adherence, Medication

Interventions: Device: Vaginal Renewal Program

Registration Number: NCT03739983

Lead Sponsor: University of Wisconsin, Madison

Brief Summary: Breast cancer patients commonly take medications to reduce the risk of recurrence, including aromatase inhibitors (AIs). AIs can cause significant side effects that reduce patient adherence. Early discontinuation of AI therapy results in an increased risk of cancer recurrence and increased risk of breast cancer-related death. Common side effects include vaginal dryness and vulvovaginal atrophy leading to worsening sexual function. To increase AI adherence, the investigators will study a non-pharmaceutical Vaginal Renewal Program (VRP) aimed at stimulating nitric oxide production to consequently increase vaginal lubrication, and improve the symptoms of vulvovaginal atrophy.

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: Female

Target Recruitment: 2

Inclusion Criteria

Have completed active primary treatment
- defined as surgery chemotherapy and/or radiation for the treatment of breast cancer
- Does not include immunotherapy or other targeted therapies such as trastuzumab, CDK 4/6 or mTOR inhibitors
Have been receiving AIs for at least 6 months prior to enrollment
Plan to continue AIs for an additional 3 months
Amenorrhea for at least 12 months at enrollment
Participants must be able to read and write in English
Participants must have < 2% superficial vaginal cells on cytologic evaluation

Exclusion Criteria

Pre-existing hypertonic pelvic floor dysfunction identified in the medical record
Unresolved or recurrent vaginismus identified in the medical record
Aversion to touching one's own body, including genitals, or using vibration therapy on the genitals
Currently receiving estrogen therapy, including topical and/or systemic estrogens
Have received estrogen therapy within 6 months of study enrollment, including topical and/or systemic estrogens
Any surgical procedure to the vagina or vulva, excluding office biopsies, within the previous 12 months
Receipt of pelvic or vaginal or vulvar radiation therapy within the 12 months prior to enrollment or if the subject is anticipated to receive radiation targeted to any of these 3 locations within 6 months following enrollment
Any use of the VRP off study within the last 6 months

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
VRP Therapy	Vaginal Renewal Program	All subjects on this study will receive the Vaginal Renewal Program intervention. Enrolled subjects will receive inperson instruction on how to perform the VRP. Subjects will be encouraged to use the device for 3-4 days per week for 5 minutes at a time.

Primary Outcome Measures

Name	Time	Method
Percentage of Superficial Vaginal Cells	up to 12 weeks	The investigators expect the percentage of superficial vaginal cells to be greater at the post-intervention time point when compared to the pre-intervention time point. If the percentage of superficial vaginal cells is ≥ 4% following the intervention, then the response will be considered positive.

Secondary Outcome Measures

Name	Time	Method
Patient Reported Outcomes: Number of Subjects With Improved Anxiety	up to 12 weeks	Number of subjects with improved anxiety outcomes per over baseline. The PROMIS (Patient Reported Outcomes Measurement Information System) Emotional Distress - Anxiety scale measures patient perceived changes in anxiety and includes 8 questions that they answer about their emotional state in the past 7 days. Descriptive answers are scored from 1 (never) to 5 (always). The total possible range of scores is from 8-40, with higher scores indicating a worse outcome.
Change in Vaginal pH	up to 12 weeks	Changes in the vaginal pH will be analyzed to determine the extent to which the changes correlate with changes in the primary outcome and with patient reported outcomes. Given the longitudinal nature of the study, linear and generalized linear mixed effects models will be fit to the data gathered. The restricted maximum likelihood (REML) criterion will be used and 95% semi-parametrically bootstrapped confidence intervals will be obtained for all parameters. All statistical analyses will be conducted using R (R Core Team 2014).
Patient Reported Outcomes: Number of Subjects With Improved Sex Life	up to 12 weeks	Number of subjects with improved sex life over baseline. The PROMIS (Patient Reported Outcomes Measurement Information System) Global Satisfaction with Sex Life scale measures patient perceived changes in the satisfaction of their sex life and includes 7 questions that they answer about their perceived state. Descriptive answers include 'Not at all', 'A little bit', 'Somewhat', 'Quite a bit', or 'Very', and will be summarized with descriptive statistics.
Patient Reported Outcomes: Number of Subjects With Improved Depression	up to 12 weeks	Number of subjects with improved depression outcomes over baseline. The PROMIS (Patient Reported Outcomes Measurement Information System) Emotional Distress - Depression scale measures patient perceived changes in depression and includes 8 questions that they answer about their emotional state in the past 7 days. Descriptive answers are scored from 1 (never) to 5 (always). The total possible range of scores is from 8-40, with higher scores indicating a worse outcome.
Patient Reported Outcomes: Number of Subjects With Improved Sexual Function Outcomes	up to 12 weeks	Number of subjects with improved sexual function outcomes over baseline. The PROMIS (Patient Reported Outcomes Measurement Information System) Sexual Function Profile scale measures patient perceived changes in sexual function and includes 10 questions that they answer about their functional state. Descriptive answers include 'Not at all', 'A little bit', 'Somewhat', 'Quite a bit', or 'Very', and will be summarized with descriptive statistics.
Patient Reported Outcomes: Number of Subjects With Improved Global Health	up to 12 weeks	Number of subjects with improved global health over baseline. The PROMIS (Patient Reported Outcomes Measurement Information System) Global Health scale measures patient perceived changes in health and includes 10 questions that they answer about their perceived health in the past 7 days. Higher scores indicate a higher perceived level of overall health.