Clinical trial · Interventional
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
NCT06817161CI-TRIAL-00096368ESTANVOrecruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Digestive System Disorders | — | UNRESOLVED | — |
| First Line Chemotherapy | — | UNRESOLVED | — |
| Ovarian Carcinoma | Ovarian Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo device | Device | — | UNRESOLVED |
| transcutaneous auricular vagus nerve stimulation | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental group
- description
- transcutaneous auricular vagus nerve stimulation (taVNS)
- interventionNames
- Device: transcutaneous auricular vagus nerve stimulation
- type
- PLACEBO_COMPARATOR
- label
- Control group
- description
- placebo using the same device that does not deliver electrical stimulation
- interventionNames
- Device: Placebo device
Primary outcomes (1)
- measure
- assess the 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 t
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.