Fractional CO2 Laser Therapy for Survivors of Breast Malignancies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Patient compliance rates
研究概览
简要总结
This pilot clinical trial studies how well fraction carbon dioxide (CO2) laser therapy works in treating vaginal atrophy in patients with breast cancer. Fraction CO2 laser therapy uses intense beams of light to cut, burn, or destroy tissue and may remodel vaginal tissue and direct controlled thermal damage of vaginal mucosa.
详细描述
PRIMARY OBJECTIVES:
I. To demonstrate the feasibility of fractionated CO2 laser treatments in patients with breast cancer with vaginal atrophy by determining treatment completion rates and tolerability of treatment.
II. To demonstrate the efficacy of fractionated CO2 laser treatments in patients with breast cancer with vaginal atrophy as determined by improvement from baseline to post treatment in the score of the Vaginal Assessment Scale (VAS).
SECONDARY OBJECTIVES:
I. Sexual behavior/function as measured by the Sexual Experiences Scare, Global sexual satisfaction scale, Female Sexual Function Index (FSFI), and the Female Sexual Distress Scare (FSDS).
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
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with non-metastatic breast cancer with any hormone receptor and Her 2 neu status who have completed surgery, chemotherapy, and radiation and are currently on endocrine therapy, single agent Herceptin, or observation
- •Symptoms of urogenital atrophy including dyspareunia or vaginal dryness
排除标准
- •Patients with metastatic breast cancer
- •Vaginal stenosis which would not allow vaginal probe to be placed (based on physician exam)
- •Active genital infection at the time of enrollment (if present initially, can be treated and then patient can be re-evaluated for eligibility)
- •Pelvic organ prolapse greater than stage II
- •Prior reconstructive pelvic surgery involving mesh
- •Hormone replacement therapy, vaginal estrogen therapy, DHEA, or biosynthetics within 6 weeks prior to enrollment
结局指标
主要结局
Patient compliance rates
时间窗: Up to 4 weeks
Compliance rates with treatment will be assessed.
Change in Vaginal Assessment Scale score
时间窗: Baseline up to 4 weeks
Using Vaginal Assessment Scale (VAS)
Feasibility of laser treatments defined by completion rates and tolerability of treatment
时间窗: Up to 4 weeks
Will evaluate if laser can be completed and tolerated will be used to summarize demographics and clinical characteristics.
次要结局
- Other symptoms of urogenital atrophy using the Urogenital Distress Inventory(Up to 4 weeks)
- Sexual behavior/function as measured by the Sexual Experiences Scare, Global sexual satisfaction scale, Female Sexual Function Index, and the Female Sexual Distress Scare(Up to 4 weeks)
研究者
Allison Quick
Principal Investigator
Ohio State University Comprehensive Cancer Center