Alterations in the Vaginal Microenvironment Using a Non-pharmacological Intervention

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-19

Study Completion Date

2020-03-10

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.

Detailed Description

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Conditions

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Adherence, Medication

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prospective Simon two-stage study design

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Vaginal Renewal Program

Intervention Type DEVICE

Therapeutic vibrating wand.

Interventions

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Vaginal Renewal Program

Therapeutic vibrating wand.

Intervention Type DEVICE

Other Intervention Names

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FeMani Vibrating Massage Wand

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ryan Spencer

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

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University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document