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Alterations in the Vaginal Microenvironment Using a Non-pharmacological Intervention

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ClinicalTrials.gov Identifier: NCT03739983
Recruitment Status : Terminated (slow accrual as a result of COVID-19)
First Posted : November 14, 2018
Results First Posted : September 28, 2021
Last Update Posted : September 28, 2021
Sponsor:
Collaborator:
American Cancer Society, Inc.
Information provided by (Responsible Party):
University of Wisconsin, Madison

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.

Condition or disease Intervention/treatment Phase
Adherence, Medication Device: Vaginal Renewal Program Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective Simon two-stage study design
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Alterations in the Vaginal Microenvironment Using a Non-pharmacological Intervention for Breast Cancer Patients Treated With Aromatase Inhibitors
Actual Study Start Date : November 19, 2019
Actual Primary Completion Date : March 10, 2020
Actual Study Completion Date : March 10, 2020

Resource links provided by the National Library of Medicine


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 Name: FeMani Vibrating Massage Wand




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Change in Vaginal pH [ Time Frame: up to 12 weeks ]
    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).

  2. Patient Reported Outcomes: Number of Subjects With Improved Anxiety [ Time Frame: up to 12 weeks ]
    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. Descriptive answers include 'Never', 'Rarely', 'Sometimes', 'Often', or 'Always', and will be summarized with descriptive statistics.

  3. Patient Reported Outcomes: Number of Subjects With Improved Depression [ Time Frame: up to 12 weeks ]
    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. Descriptive answers include 'Never', 'Rarely', 'Sometimes', 'Often', or 'Always', and will be summarized with descriptive statistics.

  4. Patient Reported Outcomes: Number of Subjects With Improved Sexual Function Outcomes [ Time Frame: up to 12 weeks ]
    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.

  5. Patient Reported Outcomes: Number of Subjects With Improved Global Health [ Time Frame: up to 12 weeks ]
    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. Descriptive answers include 'Excellent', 'Very good', 'Good', 'Fair', or 'Poor', and will be summarized with descriptive statistics.

  6. Patient Reported Outcomes: Number of Subjects With Improved Sex Life [ Time Frame: up to 12 weeks ]
    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.


Other Outcome Measures:
  1. Adherence to AI Therapy [ Time Frame: up to 12 weeks ]
    Adherence to AI therapy will be determined using patient-reported logs.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03739983


Locations
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United States, Wisconsin
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
American Cancer Society, Inc.
Investigators
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Principal Investigator: Ryan Spencer University of Wisconsin, Madison
  Study Documents (Full-Text)

Documents provided by University of Wisconsin, Madison:
Additional Information:
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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT03739983    
Other Study ID Numbers: UW17032
2018-0633 ( Other Identifier: Institutional Review Board )
A532820 ( Other Identifier: UW Madison )
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 )
First Posted: November 14, 2018    Key Record Dates
Results First Posted: September 28, 2021
Last Update Posted: September 28, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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