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

October 3, 2025 updated by: Centre Francois Baclesse

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

116

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
transcutaneous auricular vagus nerve stimulation (taVNS)
Device: transcutaneous auricular vagus nerve stimulation

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)
Placebo Comparator: Control group
placebo using the same device that does not deliver electrical stimulation
Device: Placebo device

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 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
At the beginning of Cycle 3 (each cycle is 21 days)".

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The evolution of heart rate variability (HRV) during chemotherapy between the 2 groups of patients
Time Frame: 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
Measured at inclusion and on day 1 of each course before chemotherapy infusion
The safety profile
Time Frame: 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
During chemotherapy (6 cycles, each cycle is 21 days), so up to 5 months after inclusion
The compliance with the use of the device
Time Frame: 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
During chemotherapy (6 cycles, each cycle is 21 days), so up to 5 months after inclusion
- The evolution of markers of inflammation (NLR, CRP, Albumin) during chemotherapy
Time Frame: 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,
At inclusion and during cycles 3 and 6 of chemotherapy (each cycle is 21 days)
Quality of life during chemotherapy
Time Frame: 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
At inclusion, at courses 3 and 6 of chemotherapy (each cycle is 21 days)
The dose-intensity of chemotherapy in first-line treatment
Time Frame: During chemotherapy (6 cycles, each cycle is 21 days), so up to 5 months after inclusion
Dose of chemotherapy delivered per time unit
During chemotherapy (6 cycles, each cycle is 21 days), so up to 5 months after inclusion
The progression-free survival
Time Frame: 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)
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Francois Baclesse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 30, 2025

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

September 30, 2028

Study Registration Dates

First Submitted

January 29, 2025

First Submitted That Met QC Criteria

February 4, 2025

First Posted (Actual)

February 10, 2025

Study Record Updates

Last Update Posted (Estimated)

October 7, 2025

Last Update Submitted That Met QC Criteria

October 3, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESTANVO
  • 2024-A01527-40 (Registry Identifier: ID-RCB number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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