Phase I Pilot Study Evaluating Vaginal Dilator Use and Toxicity Following Vaginal Brachytherapy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Vaginal dilator adherence, measured by the average number of times per week patient uses a form of vaginal dilation
研究概览
简要总结
This randomized, pilot phase I trial studies whether phone or email reminders increases vaginal dilator use in patients with endometrial, cervical, or vaginal cancers after they undergo brachytherapy. Brachytherapy is a type of internal radiation which uses radioactive material placed directly into or near a tumor to kill tumor cells. A reminder program may help increase use of vaginal dilators and decrease long-term side effects following brachytherapy.
详细描述
PRIMARY OBJECTIVES:
I. Evaluate whether vaginal dilator adherence is improved with additional reminder phone calls and/or email reminder survey.
SECONDARY OBJECTIVES:
I. Evaluate whether there are differences in the length of vaginal canal between the non-intervention and intervention groups. Evaluate rates of gynecologic, urinary, and gastrointestinal toxicity.
OUTLINE: Patients are randomized to 1 of 3 arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Patients with gynecologic cancer who are undergoing vaginal brachytherapy as part of their treatment
- •Patients cannot have previously received pelvic external beam radiation or brachytherapy. Patients may be enrolled while undergoing vaginal brachytherapy radiation treatment.
- •Patients should have a life expectancy of at least 1 year
- •No Eastern Cooperative Oncology Group (ECOG) or Karnofsky performance status requirements
- •No organ and marrow function requirements
- •Ability to understand and the willingness to sign a written informed consent document
排除标准
- •Patients who have received prior pelvic external beam radiation or brachytherapy will be excluded
- •No restrictions regarding use of other investigational agents
- •No exclusion requirements due to co-morbid disease or intercurrent illness
- •No investigational agent, so no exclusion requirements regarding history of allergic reactions attributed to compounds of similar chemical or biologic composition to investigational agent or device
- •No exclusion criteria relating to concomitant medications
- •No exclusion criteria for pregnant or nursing patients from participating in this study (Of note, pregnant patients will not be treated with vaginal brachytherapy, a requirement for enrolling on this study)
结局指标
主要结局
Vaginal dilator adherence, measured by the average number of times per week patient uses a form of vaginal dilation
时间窗: Up to 25 months after completing radiation
The vaginal dilator adherence measurements will analyzed in repeated measures model with treatment as a fixed effect and time as a within subject effect. The overall mean of vaginal dilator adherence among the 3 groups will also be measured and compared. The interaction between treatment and time will also be tested to see if the behavior over time is different depending on which treatment arm the patient is in.
次要结局
- Vaginal canal length(Up to 25 months after completing radiation)
- Incidence of adverse events (AE), reported by type and grade using the Common Terminology Criteria for Adverse Events version 4.03(Up to 30 days after the last dose of study treatment)