Ovarian CarcinomaPhase 3ESTANVONCT06817161
Benefit of Transcutaneous Auricular Vagus Nerve Stimulation in Improving Quality of Life in First Line Treatment of Ovarian Cancer:
A Phase 3 study testing transcutaneous auricular vagus nerve stimulation in people with Ovarian Carcinoma and First Line Chemotherapy, run by Centre Francois Baclesse at 4 sites in France.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Carcinoma, First Line Chemotherapy, Digestive System Disorders
- What is being tested?
- transcutaneous auricular vagus nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- 4 sitesFrance
- Study dates
- 30 Apr 2025to 30 Sep 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites, 4 recruiting
- Recruiting
Centre François Baclesse
Caen
François CHERIFI, 33-231455050, f.cherifi@baclesse.unicancer.fr
- Not yet recruiting
CHU CAEN
Caen
Angélique DA SILVA, 33-231063131, dasilva-a@chu-caen.fr
- Not yet recruiting
Centre Oscar Lambret
Lille
Nora ALLOY, 33-3 20 29 59 59, investigation@o-lambret.fr
- Not yet recruiting
Centre Henri Becquerel
Rouen
Sophie GOUERANT, 33-232082985, sophie.gouerant@chb.unicancer.fr
About this study
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
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
Read the 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
- Being tested
- transcutaneous auricular vagus nerve stimulation, Placebo device
- Keywords
- ovarian carinoma, parasympathetic, vagus nerve, transcutaneous auricular stimulation, quality of life, digestive symptoms
- Medical subject headings
- Ovarian Neoplasms, Digestive System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcutaneous auricular vagus nerve stimulationDevice
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 deviceDevice
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)
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | transcutaneous auricular vagus nerve stimulation (taVNS) Receives: Device: transcutaneous auricular vagus nerve stimulation |
| Control group | Placebo comparator | placebo using the same device that does not deliver electrical stimulation Receives: Device: Placebo device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Score of the QoL dimension relating to digestive symptoms according to the EORTC QLQ-OV28 self-questionnaire
Measured: At the beginning of Cycle 3 (each cycle is 21 days)".
Secondary outcomes (7)
The evolution of heart rate variability (HRV) during chemotherapy between the 2 groups of patients
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: Measured at inclusion and on day 1 of each course before chemotherapy infusion
The safety profile
Adverse events with regards to the use of the device, according to NCI-CTCAE V5.0
Measured: During chemotherapy (6 cycles, each cycle is 21 days), so up to 5 months after inclusion
The compliance with the use of the device
Number of daily taVNS stimulations and stimulation durations, taVNS (electrical) frequencies, according to ear device recordings
Measured: 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
- Blood concentrations of inflammatory markers : Neutrophil to Lymphocyte Ratio (NLR), CRP, Albumin,
Measured: At inclusion and during cycles 3 and 6 of chemotherapy (each cycle is 21 days)
Quality of life during chemotherapy
Quality of life scores according to the standardized self-questionnaire EORTC QLQ-C30
Measured: At inclusion, at courses 3 and 6 of chemotherapy (each cycle is 21 days)
The dose-intensity of chemotherapy in first-line treatment
Dose of chemotherapy delivered per time unit
Measured: During chemotherapy (6 cycles, each cycle is 21 days), so up to 5 months after inclusion
The progression-free survival
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)
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start30 Apr 2025
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized double-blind prospective multicenter study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Francois Baclesse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06817161
- Sponsor's protocol ID
- ESTANVO
- Other IDs
- 2024-A01527-40
- Acronym
- ESTANVO
- Status last verified
- Aug 2025
- First submitted
- 29 Jan 2025
- Last updated
- 7 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06817161
- Acronym / sponsor ID
- ESTANVO / ESTANVO
- Keywords
- ovarian carinoma, parasympathetic, vagus nerve, transcutaneous auricular stimulation, quality of life, digestive symptoms
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Centre Francois BaclesseUniversity, hospital or other
- Study start
- 30 Apr 2025 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 10 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Randomized double-blind prospective multicenter study
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: transcutaneous auricular vagus nerve stimulationtranscutaneous auricular vagus nerve stimulation (taVNS) |
| Control group | Placebo comparator | Device: Placebo deviceplacebo using the same device that does not deliver electrical stimulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcutaneous auricular vagus nerve stimulationThe 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) | Device | Experimental group |
| Placebo deviceThe 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) | Device | Control group |
Primary outcome
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
7 secondary outcomes
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
The safety profile
Time frame: 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
- 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)
Quality of life during chemotherapy
Time frame: 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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing transcutaneous auricular vagus nerve stimulation in people with Ovarian Carcinoma and First Line Chemotherapy, run by Centre Francois Baclesse at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact François CHERIFI, Medical Doctor (0231455050, f.cherifi@baclesse.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: At the beginning of Cycle 3 (each cycle is 21 days)".). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2025.