Alterations in the Vaginal Microenvironment Using a Non-pharmacological Intervention

Study Overview
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Brief Summary
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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.

Official Title
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Alterations in the Vaginal Microenvironment Using a Non-pharmacological Intervention for Breast Cancer Patients Treated With Aromatase Inhibitors

Conditions
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Adherence, Medication

Intervention / Treatment
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* Device: Vaginal Renewal Program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective Simon two-stage study design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VRP Therapy<br>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. | Device: Vaginal Renewal Program<br>* Therapeutic vibrating wand.<br>* Other names: FeMani Vibrating Massage Wand;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Superficial Vaginal Cells | 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. | up to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Vaginal pH | 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). | up to 12 weeks | 
| Patient Reported Outcomes: Number of Subjects With Improved Anxiety | 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. | up to 12 weeks | 
| Patient Reported Outcomes: Number of Subjects With Improved Depression | 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. | up to 12 weeks | 
| Patient Reported Outcomes: Number of Subjects With Improved Sexual Function Outcomes | 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. | up to 12 weeks | 
| Patient Reported Outcomes: Number of Subjects With Improved Global Health | 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. | up to 12 weeks | 
| Patient Reported Outcomes: Number of Subjects With Improved Sex Life | 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. | up to 12 weeks |