Overview

Impact of stimulation of parasympathetic activity by transcutaneous auricular vagus nerve stimulation (taVNS) on quality of life (QoL) relating to digestive symptoms in patients undergoing first-line treatment for ovarian cancer, as compared to shame taVNS

Eligibility

Inclusion Criteria:

• Patient ≥ 18 years old
• ECOG 0-2
• Histologically proven epithelial ovarian carcinoma
• FIGO stage ≥ IIB
• Patient candidate for first line chemotherapy treatment (alone, neoadjuvant or adjuvant)
• Patient affiliated to an appropriate social security system
• Patient who has signed informed consent obtained before any trial related activities

Exclusion Criteria:

• Patient with an active implantable medical device or any other implanted electronic or electrical device (pacemaker, defibrillator, etc.)
• Dermatological problems in the area where stimulation electrodes are applied
• Recent history (<2 years) of epileptic seizures
• Proven severe cardiovascular disease (such as known FEV <40%, severe valvulpathy...) or HRV analysis not possible (such as uncontrolled atrial fibrillation)
• Serious ear pathology
• Documented vegetative neuropathy
• Unusual morphology of the left ear which does not allow the use of the device
• Patient with a cochlear implant near to the stimulation site
• Impaired cognitive abilities
• Concurrent other malignancy (except for appropriately treated in-situ cervix carcinoma and non-melanoma skin carcinoma)
• Pregnant or breastfeeding woman
• Simultaneous participation in another clinical study that may compromise the conduct of this study.
• Patient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol
• Patient deprived of liberty or placed under the authority of a tutor