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

Phase 3

Recruiting

• Conditions: Ovarian Carcinoma; First Line Chemotherapy; Digestive System Disorders

• Registration Number: NCT06817161
• Lead Sponsor: Centre Francois Baclesse

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

Study Timeline

• Study First Submitted: 2025-01-29
• Study First Submitted QC: 2025-02-04
• Study First Posted: 2025-02-10
• Study Start: 2025-04-30
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-02
• Last Update Posted: 2025-05-06
• Primary Completion: 2028-06-30
• Study Completion: 2028-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 116

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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	At the beginning of Cycle 3 (each cycle is 21 days)".	Score of the QoL dimension relating to digestive symptoms according to the EORTC QLQ-OV28 self-questionnaire

Secondary Outcome Measures

Name	Time	Method
The progression-free survival	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	Progression-free survival (PFS) defined as time between randomization and first disease progression according to RECIST v1.1 criteria or death whatever cause (in the absence of progression)
The evolution of heart rate variability (HRV) during chemotherapy between the 2 groups of patients	Measured at inclusion and on day 1 of each course before chemotherapy infusion	Heart Rate Variability (HRV) parameters through an electrocardiogram; as an exploratory complementary objective, for patients in Caen centres, HRV will also be measured using a Polar H10 type measuring device to determine two parameters SDDN and RMSSD
The safety profile	During chemotherapy (6 cycles, each cycle is 21 days), so up to 5 months after inclusion	Adverse events with regards to the use of the device, according to NCI-CTCAE V5.0
The compliance with the use of the device	During chemotherapy (6 cycles, each cycle is 21 days), so up to 5 months after inclusion	Number of daily taVNS stimulations and stimulation durations, taVNS (electrical) frequencies, according to ear device recordings
- The evolution of markers of inflammation (NLR, CRP, Albumin) during chemotherapy	At inclusion and during cycles 3 and 6 of chemotherapy (each cycle is 21 days)	- Blood concentrations of inflammatory markers : Neutrophil to Lymphocyte Ratio (NLR), CRP, Albumin,
The dose-intensity of chemotherapy in first-line treatment	During chemotherapy (6 cycles, each cycle is 21 days), so up to 5 months after inclusion	Dose of chemotherapy delivered per time unit
Quality of life during chemotherapy	At inclusion, at courses 3 and 6 of chemotherapy (each cycle is 21 days)	Quality of life scores according to the standardized self-questionnaire EORTC QLQ-C30

Trial Locations

Locations (4)

Centre François Baclesse; 🇫🇷 Caen, France

CHU CAEN; 🇫🇷 Caen, France

Centre Oscar Lambret; 🇫🇷 Lille, France

Centre Henri Becquerel; 🇫🇷 Rouen, France