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

Centre Hospitalier Universitaire de Saint Etienne

Status: Terminated

Conditions: Endometrial Cancer

Treatments: Other: No Virtual Reality Helmet; Device: Virtual reality Helmet

Study type: Interventional

Funder types: Other

Identifiers

NCT03324958

2017-A01919-44 (Other Identifier)

2017-0501

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Virtual Reality Helmet

Experimental group

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.

Treatment:

Device: Virtual reality Helmet

No Virtual Reality Helmet

Active Comparator group

Description:

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

Treatment:

Other: No Virtual Reality Helmet