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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorCentre Francois Baclesse

About this trial

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

Qualifiers

Patient ≥ 18 years old

ECOG 0-2

Histologically proven epithelial ovarian carcinoma

FIGO stage ≥ IIB

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • transcutaneous auricular vagus nerve stimulation
  • Placebo device

Treatment groups

116 Participants
are divided into 2 treatment groups

Sponsors and collaborators