Evaluation of Hypnosis in Virtual Reality on the Anxiety of Patients With Metastatic Prostate Cancer Over Chemotherapy (HypProMet)

Saint-Gregoire Private Hospital Center

Status: Enrolling

Conditions: Metastatic Prostate Cancer

Treatments: Device: HYPNO VR® device

Study type: Interventional

Funder types: Other

Identifiers

NCT04533958

2019-A03336-51

Details and patient eligibility

About

Prostate cancer is the first cancer in men. The treatment of metastatic prostate cancer with chemotherapy is based on the intravenous administration of docetaxel chemotherapy. Symptoms of anticipatory nausea, linked to anxiety caused by the treatment, may occur. Hypnosis is already used to treat the anxiety of people with cancer and can help treat the symtoms of nausea and vomiting of women with breast cancer.

The purpose of the study is to evaluate the effect of medical hypnosis in virtual reality on the anxiety of patients with metastatic prostate cancer receiving Docetaxel chemotherapy treatment in comparison with a control group.

Full description

After verifying the patient's eligibility criteria and obtaining the signed informed consent form, the patient is randomized to the arm receiving hypnosis in virtual reality or to the control arm. The study ends after the 12 courses of docetaxel or premature termination of the study.

Enrollment: 60 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Man aged ≥ 18 years
• Histologically proven metastatic prostate adenocarcinoma,
• Patient undergoing chemotherapy according to the following conventional scheme: 12 courses of Docetaxel every two weeks
• Patient who signed their informed consent
• Patient benefiting from social security coverage
• Patient treated and followed in the center for the duration of the study (6 months maximum).

Exclusion criteria

• Patient participating in another clinical trial on an experimental molecule
• Patient who received previous chemotherapy
• Patient unable to submit to protocol monitoring for psychological, social, family or geographic reasons
• Patient deprived of their liberty or under guardianship
• Patient with underlying or concomitant pathology incompatible with inclusion in the trial, whether psychiatric or somatic

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

HypnoVR Arm

Experimental group

Description:

During each Docetaxel infusion, patients benefit from a 20-minute session of medical hypnosis in virtual reality.

Treatment:

Device: HYPNO VR® device

Control Arm

No Intervention group

Description:

Patients receive the docetaxel infusions under standard conditions (no medical hypnosis in virtual reality intervention)