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

RecruitingPhase 3Ages 18 Years - anyFemaleCentre Francois Baclesse
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
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What it tests

  • transcutaneous auricular vagus nerve stimulation
  • Placebo device
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Where

4 sites
Centre François Baclesse
Caen, France
CHU CAEN
Caen, France
Centre Oscar Lambret
Lille, France
Centre Henri Becquerel
Rouen, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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