Benefit of Transcutaneous Auricular Vagus Nerve Stimulation in Improving Quality of Life in First Line Treatment of Ovarian Cancer:
Recruiting now · Phase 3 · Has a placebo group
Conditions studied: Ovarian Carcinoma, First Line Chemotherapy, Digestive System Disorders
In brief
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
Key facts
- Study ID
- NCT06817161
- Run by
- Centre Francois Baclesse
- People needed
- 116
- Starts
- 2025-04-30
- Expected to finish
- 2028-09-30
- Last updated by the study team
- 2025-10-07
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Centre François Baclesse — Caen, France (enrolling)
- CHU CAEN — Caen, France
- Centre Oscar Lambret — Lille, France
- Centre Henri Becquerel — Rouen, France
Full record on ClinicalTrials.gov
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