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Not yet recruiting NCT07235540

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

No phase Interventional Gynaecologic Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pelotte.
Who it may be relevant to
Registry conditions: Gynaecologic Cancer. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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.

Overview

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.

Interventions

  • Device 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

Primary outcome measures

  • • Average vaginal temperature during DHT treatments with pelotte and with a standard vaginal probe. [Time frame: approximately seven weeks from the intake with the radiation oncologist to the last treatment administration]
Secondary outcome measures (4)
  • Inter-fractional reproducibility of the catheter placement in depth and position with pelotte and with a standard vaginal probe. [Time frame: 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. [Time frame: 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 [Time frame: 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. [Time frame: Approximately seven weeks from the intake with the radiation oncologist to the last treatment administration.]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Other

Study locations

Netherlands · 1 center
  • Erasmus MC — Rotterdam

Identifiers

NCT: NCT07235540 · NL-010698

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗