More Representative Vaginal Temperature Measurements With a Hyperthermia Pelotte During Hyperthermia Treatments for Gynaecological Cancer.

Официальное название

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.

Обзор

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.

Вмешательства

• Устройство Pelotte
  The pelotte is a medical device. It is a round rod made of PTFE - polytetrafluoroethylene (figure 3). The top 7 cm has a diameter of 20 mm and the bottom 13 cm has a diameter of 11 mm. One disposable catheter for temperature measurements will be attached to the pelotte with tape. This catheter will be placed ventrally on the pelotte. A thermometer will be placed in this catheter. This thermometer will measure the vaginal temperatures. A condom is then placed over the pelotte and the catheter bef

Первичные конечные точки

• • Average vaginal temperature during DHT treatments with pelotte and with a standard vaginal probe. [Срок оценки: approximately seven weeks from the intake with the radiation oncologist to the last treatment administration]

Вторичные конечные точки (4)

• Inter-fractional reproducibility of the catheter placement in depth and position with pelotte and with a standard vaginal probe. [Срок оценки: 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. [Срок оценки: 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 [Срок оценки: 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. [Срок оценки: Approximately seven weeks from the intake with the radiation oncologist to the last treatment administration.]

Критерии участия

Критерии включения

• Women aged 18 or older diagnosed with gynaecological cancer
• Indication for EBRT with DHT
• Written informed consent

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Нидерланды · 1 центр

• Erasmus MC — Rotterdam

Идентификаторы

NCT: NCT07235540 · NL-010698

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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