Brief Title
VIrtual REality Glasses for the Enhancement of Acute BRACHYtherapy Tolerance for Endometrial Cancer Patients.
Official Title
VIrtual REality Glasses for the Enhancement of Acute BRACHYtherapy Tolerance for Endometrial Cancer Patients.
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 Type
Interventional
Primary Outcome
Mean pain during brachytherapy applicator installations
Secondary Outcome
Pain during brachytherapy applicator installations, independently at each fraction
Condition
Endometrial Cancer
Intervention
Virtual reality Helmet
Study Arms / Comparison Groups
Virtual Reality Helmet
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
24
Start Date
March 26, 2019
Completion Date
March 4, 2021
Primary Completion Date
December 1, 2020
Eligibility Criteria
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.
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Nicolas Magné, PhD, ,
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT03324958
Organization ID
2017-0501
Secondary IDs
2017-A01919-44
Responsible Party
Sponsor
Study Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
Study Sponsor
Nicolas Magné, PhD, Principal Investigator, Institut de Cancérologie Lucien Neuwirth
Verification Date
February 2022