Clinical trial NCT06817161: Benefit of Transcutaneous Auricular Vagus Nerve Stimulation in Improving
        Quality of Life in First Line Treatment of Ovarian Cancer:
Official title: Benefit of Transcutaneous Auricular Vagus Nerve Stimulation in Improving Quality of Life in First Line Treatment of Ovarian Cancer: the ESTANVO Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Ovarian Carcinoma
First Line Chemotherapy
Digestive System Disorders
Keywords: ovarian carinoma
parasympathetic
vagus nerve
transcutaneous auricular stimulation
quality of life
digestive symptoms
Lead sponsor: Centre Francois Baclesse
Sponsor class: OTHER
First posted: 2025-02-10
Enrollment: 116
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized double-blind prospective multicenter study
Primary purpose: OTHER

Brief 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

Detailed description: 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

Randomization between:

* Experimental group: transcutaneous auricular vagus nerve stimulation (taVNS)
* Control group: placebo using the same device that does not deliver electrical stimulation

Eligibility criteria: 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

Primary outcomes:
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
timeFrame: At the beginning of Cycle 3 (each cycle is 21 days)".
Secondary outcomes:
measure: The evolution of heart rate variability (HRV) during chemotherapy between the 2 groups of patients
timeFrame: Measured at inclusion and on day 1 of each course before chemotherapy infusion
measure: The safety profile
timeFrame: During chemotherapy (6 cycles, each cycle is 21 days), so up to 5 months after inclusion
measure: The compliance with the use of the device
timeFrame: During chemotherapy (6 cycles, each cycle is 21 days), so up to 5 months after inclusion
measure: - The evolution of markers of inflammation (NLR, CRP, Albumin) during chemotherapy
timeFrame: At inclusion and during cycles 3 and 6 of chemotherapy (each cycle is 21 days)
measure: Quality of life during chemotherapy
timeFrame: At inclusion, at courses 3 and 6 of chemotherapy (each cycle is 21 days)
measure: The dose-intensity of chemotherapy in first-line treatment
timeFrame: During chemotherapy (6 cycles, each cycle is 21 days), so up to 5 months after inclusion
measure: The progression-free survival
timeFrame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Other outcomes:
Locations:
city: Caen
country: France
facility: Centre François Baclesse
city: Caen
country: France
facility: CHU CAEN
city: Lille
country: France
facility: Centre Oscar Lambret
city: Rouen
country: France
facility: Centre Henri Becquerel
Study officials:
References: