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
Centre Francois Baclesse
116 participants
Apr 30, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria7
- 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 Criteria14
- 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
Interventions
The intervention begins on the first day of chemotherapy and continues daily until 21 days after the end of chemotherapy (6 cycles). The dispositive is used every day at home, twice daily (during 30 minutes)
The intervention begins on the first day of chemotherapy and continues daily until 21 days after the end of chemotherapy (6 cycles). The dispositive is used every day at home, twice daily (during 30 minutes)
Locations(4)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06817161