Alterations in the Vaginal Microenvironment Using a Non-pharmacological Intervention

University of Wisconsin (UW)

Status and phase: Terminated; Phase 2

Conditions: Adherence, Medication

Treatments: Device: Vaginal Renewal Program

Study type: Interventional

Funder types: Other

Identifiers

NCT03739983

Protocol Version 10/3/2019 (Other Identifier)

SMPH/OBSTET & GYNEC/GYNEC ONC (Other Identifier)

A532820 (Other Identifier)

UW17032

2018-0633 (Other Identifier)

NCI-2018-02729 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

2 participants in 1 patient group

VRP Therapy

Experimental group

Description:

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.

Treatment:

Device: Vaginal Renewal Program