NCT06817161 Benefit of Transcutaneous Auricular Vagus Nerve Stimulation in Improving Quality of Life in First Line Treatment of Ovarian Cancer:
| NCT ID | NCT06817161 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Centre Francois Baclesse |
| Condition | Ovarian Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 116 participants |
| Start Date | 2025-04-30 |
| Primary Completion | 2028-06-30 |
Trial Parameters
Eligibility Fast-Check
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Brief 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 Criteria
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