Clinical trial NCT03739983: Alterations in the Vaginal Microenvironment Using a Non-pharmacological Intervention
Official title: Alterations in the Vaginal Microenvironment Using a Non-pharmacological Intervention for Breast Cancer Patients Treated With Aromatase Inhibitors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Adherence, Medication
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2018-11-14
Enrollment: 2
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective Simon two-stage study design
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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

Primary outcomes:
measure: Percentage of Superficial Vaginal Cells
timeFrame: up to 12 weeks
Secondary outcomes:
measure: Change in Vaginal pH
timeFrame: up to 12 weeks
measure: Patient Reported Outcomes: Number of Subjects With Improved Anxiety
timeFrame: up to 12 weeks
measure: Patient Reported Outcomes: Number of Subjects With Improved Depression
timeFrame: up to 12 weeks
measure: Patient Reported Outcomes: Number of Subjects With Improved Sexual Function Outcomes
timeFrame: up to 12 weeks
measure: Patient Reported Outcomes: Number of Subjects With Improved Global Health
timeFrame: up to 12 weeks
measure: Patient Reported Outcomes: Number of Subjects With Improved Sex Life
timeFrame: up to 12 weeks
Other outcomes:
measure: Adherence to AI Therapy
timeFrame: up to 12 weeks
Locations:
city: Madison
country: United States
facility: University of Wisconsin Carbone Cancer Center
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Ryan Spencer
role: PRINCIPAL_INVESTIGATOR
References: