Adherence, MedicationPhase 2NCT03739983

Alterations in the Vaginal Microenvironment Using a Non-pharmacological Intervention

A Phase 2 study testing Vaginal Renewal Program in people with Adherence, Medication, run by University of Wisconsin, Madison at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Adherence, Medication
What is being tested?: Vaginal Renewal Program
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2 participants
Where: 1 siteUnited States
Study dates: 19 Nov 2019to 10 Mar 2020
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53792

Other trials in United States

About this study

Official title: 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.

Conditions: Adherence, Medication
Being tested: Vaginal Renewal Program
Medical subject headings: Medication Adherence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Vaginal Renewal ProgramDevice
Also called FeMani Vibrating Massage Wand
Therapeutic vibrating wand.

Study groups in NCT03739983
Study group	Role	What they receive
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. Receives: Device: Vaginal Renewal Program

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: up to 12 weeks

Secondary outcomes (6)

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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: up to 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Nov 201910 Mar 2020

First posted14 Nov 2018
Study start19 Nov 2019
Primary completion10 Mar 2020
Study completion10 Mar 2020

Why it stopped: slow accrual as a result of COVID-19

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Adherence, MedicationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Model description: Prospective Simon two-stage study design
Masking: None (open label)
Enrolment: 2 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03739983
Sponsor's protocol ID: UW17032
Other IDs: 2018-0633, A532820, SMPH/OBSTET & GYNEC/GYNEC ONC, NCI-2018-02729, Protocol Version 10/3/2019
Status last verified: Aug 2021
First submitted: 9 Nov 2018
Last updated: 20 Oct 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 20 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Alterations in the Vaginal Microenvironment Using a Non-pharmacological Intervention for Breast Cancer Patients Treated With Aromatase Inhibitors
ClinicalTrials.gov ID: NCT03739983
Acronym / sponsor ID: UW17032
Conditions: Adherence, Medication
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: slow accrual as a result of COVID-19
Enrolment: 2 participants (actual)
Lead sponsor: University of Wisconsin, MadisonUniversity, hospital or other
Collaborators: American Cancer Society, Inc.
Study start: 19 Nov 2019 (actual)
Primary completion: 10 Mar 2020 (actual)
Study completion: 10 Mar 2020 (actual)
First posted: 14 Nov 2018 (actual)
Results: Posted 28 Sep 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Prospective Simon two-stage study design

Arm	Type	Receives
VRP Therapy	Experimental	Device: Vaginal Renewal ProgramAll 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.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Have completed active primary treatment
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

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Vaginal Renewal ProgramAlso: FeMani Vibrating Massage WandTherapeutic vibrating wand.	Device	VRP Therapy

Primary outcome

Percentage of Superficial Vaginal Cells
Time frame: 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.

6 secondary outcomes

Change in Vaginal pH
Time frame: up to 12 weeks
Patient Reported Outcomes: Number of Subjects With Improved Anxiety
Time frame: up to 12 weeks
Patient Reported Outcomes: Number of Subjects With Improved Depression
Time frame: up to 12 weeks
Patient Reported Outcomes: Number of Subjects With Improved Sexual Function Outcomes
Time frame: up to 12 weeks
Patient Reported Outcomes: Number of Subjects With Improved Global Health
Time frame: up to 12 weeks
Patient Reported Outcomes: Number of Subjects With Improved Sex Life
Time frame: up to 12 weeks

Results and safety

Results posted to the registry on 28 Sep 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
VRP Therapy	2	2

Primary outcome: Percentage of Superficial Vaginal Cells

Time frame: up to 12 weeks

Population analysed: End of study samples unavailable, decision was made not to analyze primary outcome as it was not powered to produce meaningful results.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: up to 3 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
VRP Therapy	0 of 2 (0%)	2 of 2 (100%)	0 of 2

Limitations and caveats (from the sponsor): This study was terminated early with 2 participants due to the COVID-19 pandemic. It is not powered for meaningful results.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
University of Wisconsin Carbone Cancer CenterLink provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ryan Spencer principal investigator

University of Wisconsin, Madison

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Vaginal Renewal Program in people with Adherence, Medication, run by University of Wisconsin, Madison at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 20 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Superficial Vaginal Cells (time frame: up to 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03739983.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2021.