Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2026-03-11 @ 4:43 PM
Study NCT ID:
NCT03324958
Status:
TERMINATED
Last Update Posted:
2022-02-08
First Post:
2017-10-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
VIrtual REality Glasses for the Enhancement of Acute BRACHYtherapy Tolerance for Endometrial Cancer Patients.
Sponsor:
Centre Hospitalier Universitaire de Saint Etienne
Organization:
Study Overview
Official Title:
VIrtual REality Glasses for the Enhancement of Acute BRACHYtherapy Tolerance for Endometrial Cancer Patients.
Status:
TERMINATED
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Enrollment difficulties
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Vire-Brachy
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2017-A01919-44 | OTHER | ANSM | View |