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NCT06817161RecruitingPhase 3

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

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

Source: ClinicalTrials.gov · Last updated 7 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
116 (estimated)
First submitted
29 Jan 2025
Start date
30 Apr 2025
Primary completion date
30 Jun 2028
Lead sponsor
Centre Francois Baclesse
NCT number
NCT06817161

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 116
  • From 30 Apr 2025 to the primary completion date, 30 Jun 2028
  • 4 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patient with a cochlear implant near to the stimulation site
  • Concurrent other malignancy (except for appropriately treated in-situ cervix carcinoma and non-melanoma skin carcinoma)

Other illness

  • Proven severe cardiovascular disease (such as known FEV \<40%, severe valvulpathy…) or HRV analysis not possible (such as uncontrolled atrial fibrillation)

Age

  • Recent history (\<2 years) of epileptic seizures

Other

  • 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
  • Serious ear pathology
  • Documented vegetative neuropathy
  • Unusual morphology of the left ear which does not allow the use of the device
  • Impaired cognitive abilities
  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (4)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Centre François Baclesse
Coordinator of this site? Confirm its status
CaenFranceRecruiting
CHU Caen
Coordinator of this site? Confirm its status
CaenFranceNot yet recruiting
Centre Oscar Lambret
Coordinator of this site? Confirm its status
LilleFranceNot yet recruiting
Centre Henri Becquerel
Coordinator of this site? Confirm its status
RouenFranceNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.