NCT01738152已完成不适用
A Single-Arm Clinical Trial Investigating the Feasibility of a Non-Hormonal Vaginal Moisturizer in Hormone-Receptor Positive Postmenopausal Cancer Survivors Experiencing Estrogen Deprivation Symptoms on Vulvovaginal Health
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- investigate feasibility of conducting a 12-week HLA treatment regimen
研究概览
简要总结
The purpose of this study is to see whether it is feasible to conduct a study to determine if the use of hyaluronic acid (HLA) vaginal gel (HyaloGYN®) improves vulvovaginal health.
This study aims to look at whether or not HyaloGYN® is effective in women with a history of hormone receptor positive cancer and experiencing vaginal and/or vulvar symptoms of estrogen deprivation following their breast and endometrial cancer treatment.
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
- 否
入选标准
- •History of breast cancer or endometrial cancer confirmed at MSKCC or outside pathology report
- •Breast cancer patients must be at least 3 months post-active treatment (including chemotherapy, radiation therapy, endocrine therapy, and/or maintenance therapy), but not greater than 5 years post-active treatment (exception: AIs are required, and monoclonal antibodies are allowed)
- •Breast cancer patients must be currently on adjuvant aromatase inhibitors
- •Endometrial cancer patients must be at least 3 months post-active chemotherapy and/or maintenance therapy treatment but not greater than 5 years post-active chemotherapy and/or maintenance therapy treatment. They must be at least 4 weeks post-radiation therapy (EBRT or IVRT) but not greater than 5 years post-radiation therapy.
- •Endometrial cancer patients must have underwent surgical treatment (total abdominal hysterectomy ([TAH]/BSO)) and radiation therapy (external beam radiation therapy [EBRT] or IVRT)
- •Currently have no clinical evidence of disease
- •Menopausal at study entry as described by:
- •Surgical menopause (TAH/BSO), or
- •Age ≥ 50 years and cessation of menstruation for at least 1 year, or
- •Age <50 years and cessation of menstruation for at least 1 year with estradiol level in post-menopausal range, or
- •Rendered post-menopausal with the use of LHRH agonist
- •Patients who are new visits to Female Sexual Medicine Program or patients are not consistently using any vulvovaginal health promotion strategies (e.g., pelvic floor exercises, dilator therapy, moisturizers) recommended by the Female Sexual Medicine Program Reporting being bothered by vulvovaginal symptoms of estrogen deprivation (i.e., vulvovaginal dryness or discomfort [pain with intercourse or examination])
- •Without history of other cancers (excluding non-melanoma skin cancer)
- •Women at least 18 years of age
- •Able to read and speak English
- •Able to participate in the informed consent process
排除标准
- •Inability to provide informed consent
- •Vaginal bleeding of unknown etiology within 12 months of study entry
- •Currently taking hormone replacement therapy [local or systemic] (Patients must discontinue for 2 weeks in order to be eligible prior to study enrollment)
结局指标
主要结局
investigate feasibility of conducting a 12-week HLA treatment regimen
时间窗: 12-week
a 12-week HLA treatment regimen, as defined by the percentage of women who are evaluable at the 12-week assessment (i.e., women who have completed both baseline and 12-week vaginal and vulvar outcome assessments).
次要结局
- Vaginal Assessment Composite Score [VAS](12 weeks post-HLA treatment initiation)
- Vulvar Assessment Composite Score [VuAS](12 weeks post-HLA treatment initiation)
研究者
研究点 (1)
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