A Prospective Trial to Assess Breast Cancer Survivors and Vaginal Atrophy Treatment
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Sexual dysfunction
研究概览
简要总结
The focus of this study is to assess breast cancer survivors perspectives of Viveve® Treatment using patient reported outcome tools with a focus on symptoms associated with vulvovaginal atrophy/genitourinary syndrome of menopause (GSM). This will be assessed by the FSFI, FSDS-R and DIVA questionnaires.
详细描述
Breast cancers that are hormone sensitive require estrogen suppression as a part of multimodal treatment. Estrogen suppression also reduces the likelihood of a breast cancer recurrence. Therefore, breast cancer survivors with estrogen sensitive tumors are placed on hormone suppression therapy with either selective estrogen receptor modulators like tamoxifen or aromatase inhibitors like anastrazole. This therapy typically is administered for five years after a cancer diagnosis. Regardless of age or pre-existing menopausal status, the hormone suppression reduces estrogen levels and can either exacerbate existing menopausal symptoms or induce medical menopause in otherwise premenopausal women. This study will evaluate the patient's perspective of vaginal therapy using the Viveve® device in breast cancer patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- 是
入选标准
- •18 years or older
- •Breast cancer survivors defined as women with a history of hormone sensitive breast cancer on tamoxifen
- •Self-reported vaginal laxity
- •Meet diagnosis of sexual dysfunction
- •Patients must be able to understand and willing to sign a written informed consent document and be willing to complete the patient reported outcome tools at the scheduled time points
排除标准
- •Cognitive impairment
- •Women currently on chemotherapy and/or radiation or who have had their last chemotherapy within 6 months of the intervention
- •Women with active breast cancer disease
- •Women currently on hormone therapy or who are pregnant
- •Women who have had vaginal or pelvic surgery involving the genitalia
研究组 & 干预措施
Viveve treatment
Group of women who receive Viveve treatment
干预措施: Viveve® (Device)
结局指标
主要结局
Sexual dysfunction
时间窗: Baseline, 1 month, 3 months, 6 months
Measurement of changes in sexual dysfunction using the Female Sexual Function Index (FSFI)
次要结局
- Sexual distress(Baseline, 1 month, 3 months, 6 months)
- Vaginal symptoms(Baseline, 1 month, 3 months, 6 months)
- Vaginal laxity(Baseline, 1 month, 3 months, 6 months)
研究者
W. Grant Stevens, MD
Director
Marina Plastic Surgery