VIrtual REality Glasses for the Enhancement of Acute BRACHYtherapy Tolerance for Endometrial Cancer Patients. (Vire-Brachy)

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.

Study Overview

• Status: Terminated
• Conditions: Endometrial Cancer
• Intervention / Treatment: Device: Virtual reality Helmet; Other: No Virtual Reality Helmet

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Saint-Priest-en-Jarez, France, 42270
    • Institut de Cancérologie Lucien Neuwirth
  • Villejuif, France, 94805
    • Institut Gustave Roussy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Device: 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.
ACTIVE_COMPARATOR: No Virtual Reality Helmet; Patient wont use virtual reality helmet during brachytherapy applicator setting up, as in current practice.	Other: No Virtual Reality Helmet; The radiotherapists can freely dialogue with the patients during the brachytherapy applicator' seating up, as in current practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean pain during brachytherapy applicator installations	Pain assessment will be done with visual analogue scale pain (line of 10 centimeters without graduation : beginning of the line means no pain, and the terminal extremity means worst pain ever felt), before and after brachytherapy applicator setting up	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain during brachytherapy applicator installations, independently at each fraction	Pain assessment will be done with visual analogue scale pain (line of 10 centimeters without graduation : beginning of the line means no pain, and the terminal extremity means worst pain ever felt), before and after brachytherapy applicator setting up.	1 week
Mean anxiety during brachytherapy applicator installations	Anxiety assessment will be done with visual analogue scale (line of 10 centimeters without graduation : beginning of the line means no pain, and the terminal extremity means worst pain ever felt) anxiety, before and after brachytherapy applicator setting up, and with Hamilton scale (scores will be comprised between 0 : no anxiety, and 30 : maximal anxiety) before brachytherapy applicator setting up.	1 week
Quality of life, six to height weeks after brachytherapy	Quality of life assessment will be done with the the endometrial cancer (EC)-specific Quality of Life module of the European Organization for Research and Treatment of Cancer (EORTC QLQ-EN24).	6 to 8 weeks after brachytherapy
Anxiety and depression, six to height weeks after brachytherapy	Anxiety and depression will be assessed six to height weeks after brachytherapy with the Hamilton Anxiety and Depression scale (scores will be comprised between 0 : no anxiety, and 30 : maximal anxiety).	6 to 8 weeks after brachytherapy
Correlation between mean pain during brachytherapy applicator setting up and age	Correlation will potentially be established between pain during brachytherapy applicator setting up and age.	1 week
Correlation between mean pain during brachytherapy applicator setting up and G8 scale.	Correlation will potentially be established between pain during brachytherapy applicator setting up and G8 scale.	1 week
Correlation between mean pain during brachytherapy applicator setting up and histologic type of cancer.	Correlation will potentially be established between pain during brachytherapy applicator setting up and histologic type of cancer.	1 week
Correlation between mean pain during brachytherapy applicator setting up and FIGO stage.	Correlation will potentially be established between pain during brachytherapy applicator setting up and FIGO stage.	1 week
Correlation between mean pain during brachytherapy applicator setting up and Performance status.	Correlation will potentially be established between pain during brachytherapy applicator setting up and Performance status.	1 week
Correlation between mean pain during brachytherapy applicator setting up and patient weight.	Correlation will potentially be established between pain during brachytherapy applicator setting up and patient weight.	1 week
Correlation between mean pain during brachytherapy applicator setting up and marital status.	Correlation will potentially be established between pain during brachytherapy applicator setting up and marital status.	1 week
Correlation between mean pain during brachytherapy applicator setting up and socio educational status	Correlation will potentially be established between pain during brachytherapy applicator setting up and socio educational status.	1 week
Correlation between mean pain during brachytherapy applicator setting up and number of pregnancies.	Correlation will potentially be established between pain during brachytherapy applicator setting up and number of pregnancies.	1 week
Correlation between mean pain during brachytherapy applicator setting up and history of pelvic surgery	Correlation will potentially be established between pain during brachytherapy applicator setting up and history of pelvic surgery.	1 week
Correlation between mean pain during brachytherapy applicator setting up and the number of concomitant treatment.	Correlation will potentially be established between pain during brachytherapy applicator setting up and the number of concomitant treatment.	1 week
Correlation between mean pain during brachytherapy applicator setting up and the nature of concomitant treatment.	Correlation will potentially be established between pain during brachytherapy applicator setting up and the nature of concomitant treatment.	1 week
Correlation between mean pain during brachytherapy applicator setting up and the nature of cancer treatments	Correlation will potentially be established between pain during brachytherapy applicator setting up and the nature of cancer treatments.	1 week
Correlation between mean pain during brachytherapy applicator setting up and the supportive cares performed	Correlation will potentially be established between pain during brachytherapy applicator setting up and the supportive cares performed.	1 week
Correlation between mean pain during brachytherapy applicator setting up and the radiotherapy scheme	Correlation will potentially be established between pain during brachytherapy applicator setting up and the radiotherapy achievement	1 week
Correlation between mean pain during brachytherapy applicator setting up and the brachytherapy scheme	Correlation will potentially be established between pain during brachytherapy applicator setting up and the brachytherapy scheme	1 week
Correlation between mean pain during brachytherapy applicator setting up and the radiotherapy induced toxicities (describe according to the Common Terminology Criteria for Adverse Events 4.4)	Correlation will potentially be established between pain during brachytherapy applicator setting up and the radiotherapy induced toxicities (describe according to the Common Terminology Criteria for Adverse Events 4.4).	1 week
Correlation between mean pain during brachytherapy applicator setting up and the toxicities of previous brachytherapy fractions (describe according to the Common Terminology Criteria for Adverse Events 4.4).	Correlation will potentially be established between pain during brachytherapy applicator setting up and the brachytherapy induced toxicities (describe according to the Common Terminology Criteria for Adverse Events 4.4).	1 week

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Collaborators: Institut de Cancérologie de la Loire; Gustave Roussy, Cancer Campus, Grand Paris; Centre Antoine Lacassagne

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 26, 2019
• Primary Completion (ACTUAL): December 1, 2020
• Study Completion (ACTUAL): March 4, 2021

Study Registration Dates

• First Submitted: October 20, 2017
• First Submitted That Met QC Criteria: October 24, 2017
• First Posted (ACTUAL): October 30, 2017

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2022
• Last Update Submitted That Met QC Criteria: February 7, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Pain; Anxiety; Brachytherapy; Virtual reality; Endometrial cancer
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Diseases; Endometrial Neoplasms
• Other Study ID Numbers: 2017-0501; 2017-A01919-44 (OTHER: ANSM)

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