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

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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Gynaecologic Cancer
• Intervention / Treatment: Device: Pelotte

• Study Type: Interventional
• Enrollment (Estimated): 27
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: G.H Westerveld, Dr.; Phone Number: +31107041249; Email: g.westerveld@erasmusmc.nl
• Study Contact Backup: Name: A.F. Rink, PhD student; Phone Number: +31107041314; Email: a.rink@erasmusmc.nl

Study Locations

• Netherlands
  • South Holand
    • Rotterdam, South Holand, Netherlands, 3015GD
      • Erasmus MC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Group 1; Participants will be treated with a pelotte in treatment 1,3 and 5	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 before insertion into the patient. At least two treatment will be with pelotte and at least 2 with a standard vaginal probe.
Other: Group 2; Participants will be treated with a pelotte in treatment 1,2 and 4	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 before insertion into the patient. At least two treatment will be with pelotte and at least 2 with a standard vaginal probe.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
• Average vaginal temperature during DHT treatments with pelotte and with a standard vaginal probe.	To compare if the average vaginal measured temperature is significant different with a pelotte versus the standard vaginal probe	approximately seven weeks from the intake with the radiation oncologist to the last treatment administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inter-fractional reproducibility of the catheter placement in depth and position with pelotte and with a standard vaginal probe.	For each treatment, the free length of the vaginal probe is measured from the outer labia to the probe tip. This distance is subtracted from 293 mm to determine the internal depth of the vaginal probe. In the control room, the depth is determined based on the temperature measurements. If the measured temperature falls below 36 degrees Celsius at a certain point (e.g., 8 cm from the tip), this point is considered the probe depth. These values are then compared to assess whether there is a difference in reproducibility between treatments using the pelotte and treatments using only a vaginal probe.	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.		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		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.		Approximately seven weeks from the intake with the radiation oncologist to the last treatment administration.

Collaborators and Investigators

• Sponsor: Dr. G.H. (Henrike) Westerveld

Study record dates

Study Major Dates

• Study Start (Estimated): January 5, 2026
• Primary Completion (Estimated): January 5, 2028
• Study Completion (Estimated): January 5, 2028

Study Registration Dates

• First Submitted: November 13, 2025
• First Submitted That Met QC Criteria: November 17, 2025
• First Posted (Actual): November 19, 2025

Study Record Updates

• Last Update Posted (Actual): November 19, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Hyperthermia; Probe; Pelotte; Gynaecologic
• Additional Relevant MeSH Terms: Wounds and Injuries; Body Temperature Changes; Heat Stress Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hyperthermia
• Other Study ID Numbers: NL-010698

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No