Alterations in the Vaginal Microenvironment Using a Non-pharmacological Intervention

NCT03739983 | Terminated Phase 2 Results DMC FDA Device

• 6 other identifiers: UW170322018-0633A532820SMPH/OBSTET & GYNEC/GYNEC ONCNCI-2018-02729Protocol Version 10/3/2019
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Adherence, Medication

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change in Vaginal pH

  up to 12 weeks

• Patient Reported Outcomes: Number of Subjects With Improved Anxiety

  up to 12 weeks

• Patient Reported Outcomes: Number of Subjects With Improved Depression

  up to 12 weeks

• Patient Reported Outcomes: Number of Subjects With Improved Sexual Function Outcomes

  up to 12 weeks

• Patient Reported Outcomes: Number of Subjects With Improved Global Health

  up to 12 weeks

Other Outcomes (1)

• Adherence to AI Therapy

  up to 12 weeks

Study Arms (1)

VRP Therapy

EXPERIMENTAL

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

Interventions

Vaginal Renewal Program DEVICE

Therapeutic vibrating wand.

Also known as: FeMani Vibrating Massage Wand

VRP Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• American Cancer Society, Inc.: collaborator

Study Sites (1)

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, 53792, United States

Location

Related Links

• University of Wisconsin Carbone Cancer Center

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Limitations and Caveats

This study was terminated early with 2 participants due to the COVID-19 pandemic. It is not powered for meaningful results.

Results Point of Contact

• Title: Ryan Spencer, MD, MS
• Organization: University of Wisconsin Carbone Cancer Center

rjspencer2@wisc.edu

608-265-1700

Study Officials

• Ryan Spencer

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective Simon two-stage study design

Study Record Dates

• First Submitted: November 9, 2018
• First Posted: November 14, 2018
• Study Start: November 19, 2019
• Primary Completion: March 10, 2020
• Study Completion: March 10, 2020
• Last Updated: October 20, 2021
• Results First Posted: September 28, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)