The Use of a Hyperthermia Pelotte to Acquire More Representative Vaginal Temperature Measurements During Deep Hyperthermia Treatments for Gynaecological Cancer; a Comparative Cross-over Study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- • Average vaginal temperature during DHT treatments with pelotte and with a standard vaginal probe.
研究概览
简要总结
The goal of this comparative, cross over single centre study is to to determine whether the average measured vaginal temperature during hyperthermia treatment is (clinically) significant different with the use of a pelotte than with a standard vaginal probe. in 27 women treated with external beam radiotherapy and deep hyperthermie for gynaecological cancer.. The primary endpoint is measured average vaginal temperatures with pelotte versus a standard vaginal probe.
The secondary endpoints are: reproducibility of catheter placement, patient comfort, inter-fractional spread of the vaginal temperature and the average vaginal temperature at the tip (0 cm) and 2 cm from the tip with pelotte and a standard vaginal probe.
Participants will be treated at least two time with a pelotte and two times with a standard vaginal probe. Participants will be asked to fill in a short questionnaire three times per treatment (before, during and after treatment). A total of 12-15 questionnaires will be completed by the participants over the four to five treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 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
- •Women aged 18 or older diagnosed with gynaecological cancer
- •Indication for EBRT with DHT
- •Written informed consent
排除标准
- •Any condition potentially interfering with the understanding of the study requirements, informed consent procedure and completion of questionnaires
- •If the vaginal lumen is <4 cm.
结局指标
主要结局
• Average vaginal temperature during DHT treatments with pelotte and with a standard vaginal probe.
时间窗: approximately seven weeks from the intake with the radiation oncologist to the last treatment administration
To compare if the average vaginal measured temperature is significant different with a pelotte versus the standard vaginal probe
次要结局
- Inter-fractional reproducibility of the catheter placement in depth and position with pelotte and with a standard vaginal probe.(Approximately seven weeks from the intake with the radiation oncologist to the last treatment administration)
- Patient-reported comfort with pelotte and with a standard vaginal probe, as assessed using the 'Vragenlijst Hyperthermie Pelotte' questionnaire(Approximately seven weeks from the intake with the radiation oncologist to the last treatment administration.)
- Average vaginal temperature at the measurement points of the tip (0 cm) and two cm from the tip of the catheter with pelotte and with a standard vaginal probe.(Approximately seven weeks from the intake with the radiation oncologist to the last treatment administration.)
- Inter-fractional variance in measured vaginal temperatures with pelotte and with a standard vaginal probe.(Approximately seven weeks from the intake with the radiation oncologist to the last treatment administration.)
研究者
Dr. G.H. (Henrike) Westerveld
Dr.
Erasmus Medical Center