A Novel Therapy for Breast Cancer Survivors With Genitourinary Syndrome of Menopause
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Change in GSM symptoms as measured by vulvovaginal symptom questionnaire (VSQ).
研究概览
简要总结
The purpose of this study is to determine whether platelet rich plasma (PRP) injections to the vulva and vagina will improve symptoms of genitourinary syndrome of menopause (GSM) 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
- 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
- •Female patients who are age 18 years and older
- •Patients must have a history of biopsy-proven Ductal carcinoma in situ (DCIS) or Stage I-III breast cancer and must be currently undergoing treatment or have completed primary treatment.
- •Patients must be found to have a vaginal health index (VHI) score of <
- •Patients may be currently using endocrine therapy (ovarian function suppression, tamoxifen, or aromatase inhibitors). Patients not currently using endocrine therapy will also be eligible for participation since patients more than 5 or 10 years from diagnosis (and therefore having completed adjuvant endocrine therapy) may be enrolled.
- •Some patients with triple negative breast cancer who receive chemotherapy also experience GSM related to ovarian function decline outside of the setting of ovarian suppression, and therefore patients with either ER+ or ER- breast cancer will be allowed to participate.
- •Patients must provide written informed consent for participation in this study.
- •Patients are allowed to have used non-hormonal moisturizers but if they have previously used hormonal moisturizers, they will be asked to stop the use for one month prior to the first planned treatment, termed the "washout period", if needed.
排除标准
- •Patients with any systemic or topical hormone replacement therapy within 3 months prior to enrollment, known genital infection, coagulation disorders, or on anticoagulant therapy or turmeric-containing supplements within the prior 2 weeks will be excluded.
- •Women who are pregnant or who plan to become pregnant within the following six months will be excluded since the impact of recent PRP injections to the vulva and the impact on obstetric injury during vaginal delivery has not been studied.
研究组 & 干预措施
Platelet-rich plasma (PRP) Group
Participants will undergo two sessions of platelet-rich plasma (PRP) injections to the vulva/vagina one month apart.
干预措施: Platelet-rich plasma (PRP) (Biological)
结局指标
主要结局
Change in GSM symptoms as measured by vulvovaginal symptom questionnaire (VSQ).
时间窗: Baseline, up to 31 weeks
The VSQ is a 21-question survey that specifically asks about GSM symptoms and their impact on quality of life and sexual function. Vaginal and vulvar symptoms will be self-reported using validated VSQ modified to 4-point Likert scores. VSQ consists of a series of questions, each of which is rated as 0 (never), 1(rarely), 2(sometimes), 3 (frequently). Lower scores indicate better health. Each question is analyzed separately; there is no overall score reported.
次要结局
- Change in validated female sexual function index (FSFI)(Baseline, up to 31 weeks)
- Change in sexual-related distress (FSDS-R).(Baseline, up to 31 weeks)
- Change in Vaginal health index (VHI) Score(Baseline, up to 31 weeks)
研究者
Abdulrahman Sinno, MD
Associate Professor of Clinical
University of Miami