Alterations in the Vaginal Microenvironment Using a Non-pharmacological Intervention for Breast Cancer Patients Treated With Aromatase Inhibitors
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Percentage of Superficial Vaginal Cells
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Percentage of Superficial Vaginal Cells
时间窗: 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.
次要结局
- Patient Reported Outcomes: Number of Subjects With Improved Anxiety(up to 12 weeks)
- Change in Vaginal pH(up to 12 weeks)
- Patient Reported Outcomes: Number of Subjects With Improved Sex Life(up to 12 weeks)
- Patient Reported Outcomes: Number of Subjects With Improved Depression(up to 12 weeks)
- Patient Reported Outcomes: Number of Subjects With Improved Sexual Function Outcomes(up to 12 weeks)
- Patient Reported Outcomes: Number of Subjects With Improved Global Health(up to 12 weeks)