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

Dr. G.H. (Henrike) Westerveld

Status: Not yet enrolling

Conditions: Gynaecologic Cancer

Treatments: Device: Pelotte

Study type: Interventional

Funder types: Other

Identifiers

NCT07235540

NL-010698

Details and patient eligibility

About

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.

Enrollment: 27 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

27 participants in 2 patient groups

Group 1

Other group

Description:

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

Treatment:

Device: Pelotte

Group 2

Other group

Description:

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

Treatment:

Device: Pelotte