More Representative Vaginal Temperature Measurements During Hyperthermia Treatments for Gynaecologic Cancer
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.
Run by Erasmus Medical Center · NCT07235540 · Data updated 2026-11-12
This study tests whether a pelotte provides more representative vaginal temperature readings during hyperthermia treatment for gynecologic cancer than a standard vaginal probe in women receiving radiotherapy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 27 (estimated) |
| Sponsor | Erasmus Medical Center Academic / other |
| Locations | 1 site (Rotterdam, South Holand) |
| Status | Recruiting |
| Started | January 5, 2026 |
| Main results expected | January 5, 2028 |
| Study ends | January 5, 2028 |
| Registry record updated | September 25, 2026 |
| Trial ID | NCT07235540 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 18 or older with gynecologic cancer who require EBRT with deep hyperthermia and can tolerate vaginal temperature monitoring.
✕Probably not a fit
Patients with very small vaginal lumen (<4 cm) or those unable to complete the questionnaires may not benefit from the measurement improvements.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a single-centre, cross-over interventional study in women with gynecologic cancer undergoing external beam radiotherapy and deep hyperthermia. Each participant will experience at least two treatments with a pelotte and two with a standard vaginal probe, with temperature readings collected during and after treatment. The study also collects data on catheter placement reproducibility, patient comfort, and temperature variation at different distances from the probe tip, complemented by participant questionnaires at multiple time points. The primary endpoint compares the average vaginal temperatures between the pelotte and standard probe. Secondary endpoints assess measurement consistency, comfort, and distribution of temperatures over time and space.
Why it matters
Potential benefit: If successful, the pelotte could provide more accurate and patient-friendly temperature monitoring during hyperthermia, potentially improving treatment quality.
How similar studies have gone: Previous uses of alternative vaginal temperature monitoring have shown feasibility; this study tests a specific pelotte approach in a crossover design for gynecologic cancer.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Erasmus MC
Rotterdam, South Holand, Netherlands Recruiting
Study contacts
- Study coordinator: G.H Westerveld, Dr.
- Email: g.westerveld@erasmusmc.nl
- Phone: +31107041249
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.