About this trial
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.
Eligibility criteria
Qualifiers
Women aged 18 or older diagnosed with gynaecological cancer
Indication for EBRT with DHT
Written informed consent
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Pelotte
Treatment groups
Sponsors and collaborators
Dr. G.H. (Henrike) Westerveld
Lead sponsor
Erasmus Medical Center
Sponsor institution