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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorDr. G.H. (Henrike) Westerveld

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

27 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Dr. G.H. (Henrike) Westerveld

Lead sponsor

Erasmus Medical Center

Sponsor institution