RecruitingPhase 3NCT06817161

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


Sponsor

Centre Francois Baclesse

Enrollment

116 participants

Start Date

Apr 30, 2025

Study Type

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a gentle form of nerve stimulation called transcutaneous auricular vagus nerve stimulation (taVNS) — delivered through a small device worn on the ear — can improve quality of life in women with ovarian cancer receiving first-line chemotherapy. The vagus nerve influences how the body handles stress and inflammation, and researchers believe stimulating it may help reduce side effects and improve wellbeing during treatment. **You may be eligible if...** - You are 18 or older - You have a confirmed diagnosis of epithelial ovarian cancer at stage IIB or higher - You are scheduled to start first-line chemotherapy (neoadjuvant or adjuvant) - You have given written informed consent **You may NOT be eligible if...** - You have an implanted electronic device (pacemaker, defibrillator, etc.) - You have skin problems in the ear area where the device would be placed - You have had epileptic seizures within the past 2 years - You have severe cardiovascular disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEtranscutaneous 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)

DEVICEPlacebo 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)


Locations(4)

Centre François Baclesse

Caen, France

CHU CAEN

Caen, France

Centre Oscar Lambret

Lille, France

Centre Henri Becquerel

Rouen, France

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06817161


Related Trials