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
- Diseases
- Ovarian cancer
- 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
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre François Baclesse Coordinator of this site? Confirm its status | Caen | France | Recruiting |
| CHU Caen Coordinator of this site? Confirm its status | Caen | France | Not yet recruiting |
| Centre Oscar Lambret Coordinator of this site? Confirm its status | Lille | France | Not yet recruiting |
| Centre Henri Becquerel Coordinator of this site? Confirm its status | Rouen | France | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.