Benefit of Transcutaneous Auricular Vagus Nerve Stimulation in Improving Quality of Life in First Line Treatment of Ovarian Cancer:

Summary

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

Conditions4

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