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

Last updated: May 2, 2025
Sponsor: Centre Francois Baclesse
Overall Status: Active - Recruiting

Phase

3

Condition

Ulcers

Carcinoma

Gastrointestinal Diseases And Disorders

Treatment

Placebo device

transcutaneous auricular vagus nerve stimulation

Clinical Study ID

NCT06817161
ESTANVO
2024-A01527-40
  • Ages > 18
  • Female

Study 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 Criteria

Inclusion

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 oradjuvant)

  • Patient affiliated to an appropriate social security system

  • Patient who has signed informed consent obtained before any trial related activities

Exclusion

Exclusion Criteria:

  • Patient with an active implantable medical device or any other implanted electronicor 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 cervixcarcinoma and non-melanoma skin carcinoma)

  • Pregnant or breastfeeding woman

  • Simultaneous participation in another clinical study that may compromise the conductof this study.

  • Patient assessed by the investigator to be unable or unwilling to comply with therequirements of the protocol

  • Patient deprived of liberty or placed under the authority of a tutor

Study Design

Total Participants: 116
Treatment Group(s): 2
Primary Treatment: Placebo device
Phase: 3
Study Start date:
April 30, 2025
Estimated Completion Date:
September 30, 2028

Study 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

Connect with a study center

  • CHU CAEN

    Caen,
    France

    Site Not Available

  • Centre François Baclesse

    Caen,
    France

    Active - Recruiting

  • Centre Oscar Lambret

    Lille,
    France

    Site Not Available

  • Centre Henri Becquerel

    Rouen,
    France

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.