VIrtual REality Glasses for the Enhancement of Acute BRACHYtherapy Tolerance for Endometrial Cancer Patients.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-26

Study Completion Date

2021-03-04

Brief Summary

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This randomized phase III multicenter trial aims to evaluate the impact of virtual reality helmets (visual and audio) during VCB in patients treated for endometrial cancer, in terms of pain and anxiety.

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Detailed Description

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Endometrial cancer is one of the most common gynaecological cancers among women in the developed countries. After a curative surgical treatment, many relapses occur in the vaginal cuff. The PORTEC-2 trial has demonstrated a similar reduction in local relapses of intermediate- to high-risk endometrial cancer with vaginal cuff brachytherapy (VCB) than with external beam radiotherapy (EBRT). However, VCB induced less late toxicities. VCB is therefore indicated after surgery for intermediate- to high-risk endometrial cancer. VCB is also recommended after radiation therapy, for patients with stage II or III type 1 endometrial cancers according to the International Federation of Gynaecology and Obstetrics classification (FIGO), and for all patients with histological type 2 endometrial cancers.

If the late tolerance of VCB is correct, the acute tolerance remains limited, and is mainly characterized by local pain and anxiety) Virtual reality appears to be a promising tool to enhance treatment cancer tolerance, offering a safe and entertaining environment. By the way, the use of virtual reality could limit physical and psychical discomfort induced by VCB.

This randomized phase III multicenter trial aims to assess the impact of virtual reality helmets (visual and audio) during VCB in patients treated for endometrial cancer, in terms of pain (primary endpoint), and in terms of anxiety (secondary endpoint). Randomization will define which patient will wear a virtual reality helmet. Stratification will be performed according to the following criteria: vaginal molded applicator versus cylinder, two applications versus four; \<70 years versus\> 70 years.

Conditions

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Endometrial Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Assessment of the mean local pain during brachytherapy applicator'setting up, with and without virtual reality helmet use.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Virtual Reality Helmet

Patients will use a virtual reality helmet during brachytherapy applicator's setting up. The use of virtual reality helmet has already been assessed during oncologic treatments, and seems to reduce pain and anxiety. The use of virtual reality helmet has never been assessed to reduce the pain or anxiety associated with brachytherapy applicators' setting up.

Group Type EXPERIMENTAL

Virtual reality Helmet

Intervention Type DEVICE

The virtual reality helmet will be installed by a radiotherapist or a radiotherapy manipulator, just before the intra vaginal applicator. The virtual reality headset will be connected to a dedicated computer. The virtual reality program will run for 10 minutes which will cover the entire procedure for setting up the brachytherapy device. In order to optimize the distractive potential of virtual reality, four different virtual reality programs will be offered to patients during each brachytherapy fraction. These programs will be contemplative so as not to compromise the immobility of the patients during the installation of the brachytherapy applicator.

No Virtual Reality Helmet

Patient wont use virtual reality helmet during brachytherapy applicator setting up, as in current practice.

Group Type ACTIVE_COMPARATOR

No Virtual Reality Helmet

Intervention Type OTHER

The radiotherapists can freely dialogue with the patients during the brachytherapy applicator' seating up, as in current practice.

Interventions

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Virtual reality Helmet

The virtual reality helmet will be installed by a radiotherapist or a radiotherapy manipulator, just before the intra vaginal applicator. The virtual reality headset will be connected to a dedicated computer. The virtual reality program will run for 10 minutes which will cover the entire procedure for setting up the brachytherapy device. In order to optimize the distractive potential of virtual reality, four different virtual reality programs will be offered to patients during each brachytherapy fraction. These programs will be contemplative so as not to compromise the immobility of the patients during the installation of the brachytherapy applicator.

Intervention Type DEVICE

No Virtual Reality Helmet

The radiotherapists can freely dialogue with the patients during the brachytherapy applicator' seating up, as in current practice.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients over 18 years old.
* Patients with endometrial cancer, with histological type I and II, regardless of the degree of differentiation.
* Patients with stage I, II or III endometrial cancer according to the FIGO classification.
* Patients treated with high-dose-rate vaginal cuff brachytherapy, with curative intent.
* Patients affiliated or entitled to a social security scheme.
* Patients who received information about the study and co-signed with the investigator the consent to participate at the study.

Exclusion Criteria

* Patients with stage IV endometrial cancer according to FIGO classification.
* Patients presenting recurrence of endometrial cancer.
* Pregnant or nursing women.
* Patients under protection of justice or unable to give consent.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No