Alterations in the Vaginal Microenvironment Using a Non-pharmacological Intervention

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

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.

Study Overview

• Status: Terminated
• Conditions: Adherence, Medication
• Intervention / Treatment: Device: Vaginal Renewal Program

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin Carbone Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VRP Therapy; 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; Therapeutic vibrating wand.; Other Names: FeMani Vibrating Massage Wand

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to AI Therapy	Adherence to AI therapy will be determined using patient-reported logs.	up to 12 weeks

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: American Cancer Society, Inc.
• Investigators: Principal Investigator: Ryan Spencer, University of Wisconsin, Madison

Publications and helpful links

Helpful Links

• University of Wisconsin Carbone Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2019
• Primary Completion (Actual): March 10, 2020
• Study Completion (Actual): March 10, 2020

Study Registration Dates

• First Submitted: November 9, 2018
• First Submitted That Met QC Criteria: November 9, 2018
• First Posted (Actual): November 14, 2018

Study Record Updates

• Last Update Posted (Actual): October 20, 2021
• Last Update Submitted That Met QC Criteria: September 27, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: UW17032; A532820 (Other Identifier: UW Madison); 2018-0633 (Other Identifier: Institutional Review Board); SMPH/OBSTET & GYNEC/GYNEC ONC (Other Identifier: UW Madison); NCI-2018-02729 (Registry Identifier: NCI Trial ID); Protocol Version 10/3/2019 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No