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Trials / Recruiting

RecruitingNCT06817161

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

Status
Recruiting
Phase
Phase 3
Study type
Interventional
Enrollment
116 (estimated)
Sponsor
Centre Francois Baclesse · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

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

Conditions

Interventions

TypeNameDescription
DEVICEtranscutaneous 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)
DEVICEPlacebo 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)

Timeline

Start date
2025-04-30
Primary completion
2028-06-30
Completion
2028-09-30
First posted
2025-02-10
Last updated
2025-10-07

Locations

4 sites across 1 country: France

Source: ClinicalTrials.gov record NCT06817161. Inclusion in this directory is not an endorsement.