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

Not Applicable

Terminated

• Conditions: Endometrial Cancer
• Interventions: Other: No Virtual Reality Helmet; Device: Virtual reality Helmet

• Registration Number: NCT03324958
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief Summary

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.

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 Timeline

• Study First Submitted: 2017-10-20
• Study First Submitted QC: 2017-10-24
• Study First Posted: 2017-10-30
• Study Start: 2019-03-26
• Primary Completion: 2020-12-01
• Study Completion: 2021-03-04
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-07
• Last Update Posted: 2022-02-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No Virtual Reality Helmet	No Virtual Reality Helmet	Patient wont use virtual reality helmet during brachytherapy applicator setting up, as in current practice.
Virtual Reality Helmet	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.

Primary Outcome Measures

Name	Time	Method
Mean pain during brachytherapy applicator installations	1 week	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

Secondary Outcome Measures

Name	Time	Method
Anxiety and depression, six to height weeks after brachytherapy	6 to 8 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).
Correlation between mean pain during brachytherapy applicator setting up and age	1 week	Correlation will potentially be established between pain during brachytherapy applicator setting up and age.
Correlation between mean pain during brachytherapy applicator setting up and G8 scale.	1 week	Correlation will potentially be established between pain during brachytherapy applicator setting up and G8 scale.
Correlation between mean pain during brachytherapy applicator setting up and histologic type of cancer.	1 week	Correlation will potentially be established between pain during brachytherapy applicator setting up and histologic type of cancer.
Pain during brachytherapy applicator installations, independently at each fraction	1 week	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.
Quality of life, six to height weeks after brachytherapy	6 to 8 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).
Correlation between mean pain during brachytherapy applicator setting up and FIGO stage.	1 week	Correlation will potentially be established between pain during brachytherapy applicator setting up and FIGO stage.
Correlation between mean pain during brachytherapy applicator setting up and Performance status.	1 week	Correlation will potentially be established between pain during brachytherapy applicator setting up and Performance status.
Correlation between mean pain during brachytherapy applicator setting up and the nature of concomitant treatment.	1 week	Correlation will potentially be established between pain during brachytherapy applicator setting up and the nature of concomitant treatment.
Correlation between mean pain during brachytherapy applicator setting up and the supportive cares performed	1 week	Correlation will potentially be established between pain during brachytherapy applicator setting up and the supportive cares performed.
Correlation between mean pain during brachytherapy applicator setting up and the radiotherapy scheme	1 week	Correlation will potentially be established between pain during brachytherapy applicator setting up and the radiotherapy achievement
Correlation between mean pain during brachytherapy applicator setting up and the brachytherapy scheme	1 week	Correlation will potentially be established between pain during brachytherapy applicator setting up and the brachytherapy scheme
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)	1 week	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).
Mean anxiety during brachytherapy applicator installations	1 week	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.
Correlation between mean pain during brachytherapy applicator setting up and marital status.	1 week	Correlation will potentially be established between pain during brachytherapy applicator setting up and marital status.
Correlation between mean pain during brachytherapy applicator setting up and socio educational status	1 week	Correlation will potentially be established between pain during brachytherapy applicator setting up and socio educational status.
Correlation between mean pain during brachytherapy applicator setting up and history of pelvic surgery	1 week	Correlation will potentially be established between pain during brachytherapy applicator setting up and history of pelvic surgery.
Correlation between mean pain during brachytherapy applicator setting up and patient weight.	1 week	Correlation will potentially be established between pain during brachytherapy applicator setting up and patient weight.
Correlation between mean pain during brachytherapy applicator setting up and number of pregnancies.	1 week	Correlation will potentially be established between pain during brachytherapy applicator setting up and number of pregnancies.
Correlation between mean pain during brachytherapy applicator setting up and the number of concomitant treatment.	1 week	Correlation will potentially be established between pain during brachytherapy applicator setting up and the number of concomitant treatment.
Correlation between mean pain during brachytherapy applicator setting up and the nature of cancer treatments	1 week	Correlation will potentially be established between pain during brachytherapy applicator setting up and the nature of cancer treatments.
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).	1 week	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).

Trial Locations

Locations (2)

Institut de Cancérologie Lucien Neuwirth; 🇫🇷 Saint-Priest-en-Jarez, France

Institut Gustave Roussy; 🇫🇷 Villejuif, France