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

NCT07235540 | Not Yet Recruiting DMC

• 1 other identifier: NL-010698
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gynaecologic Cancer

Keywords

Pelotte; Hyperthermia; Probe; Gynaecologic

Outcome Measures

Primary Outcomes (1)

• • 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 Outcomes (4)

• Inter-fractional reproducibility of the catheter placement in depth and position with pelotte and with a standard 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.

Study Arms (2)

Group 1

OTHER

Participants will be treated with a pelotte in treatment 1,3 and 5

Device: Pelotte

Group 2

OTHER

Participants will be treated with a pelotte in treatment 1,2 and 4

Device: Pelotte

Interventions

Pelotte DEVICE

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.

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr. G.H. (Henrike) Westerveld: lead

Study Sites (1)

Erasmus MC

Rotterdam, South Holand, 3015GD, Netherlands

Location

MeSH Terms

Conditions

Hyperthermia

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heat Stress Disorders; Wounds and Injuries

Central Study Contacts

G.H Westerveld, Dr.

CONTACT

+31107041249; g.westerveld@erasmusmc.nl

A.F. Rink, PhD student

CONTACT

+31107041314; a.rink@erasmusmc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr.

Model Details: The participants will be treated at least two treatments with pelotte and at least two with a standard vaginal probe. Based on a sample size calculation, 27 participants need to be included to achieve sufficient statistical power. Additionally, these data will be used to complete the MDR procedure for the pelotte (clinical validation).

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 19, 2025
• Study Start: January 5, 2026
• Primary Completion (Estimated): January 5, 2028
• Study Completion (Estimated): January 5, 2028
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)