Actively Recruiting
Benefit of Transcutaneous Auricular Vagus Nerve Stimulation in Improving Quality of Life in First Line Treatment of Ovarian Cancer:
Led by Centre Francois Baclesse · Updated on 2025-10-07
116
Participants Needed
4
Research Sites
178 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Benefit of Transcutaneous Auricular Vagus Nerve Stimulation in Improving Quality of Life in First Line Treatment of Ovarian Cancer:
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient 18 years old or older
- ECOG performance status between 0 and 2
- Histologically confirmed epithelial ovarian carcinoma
- FIGO stage IIB or higher
- Candidate for first line chemotherapy treatment (alone, neoadjuvant or adjuvant)
- Affiliated with an appropriate social security system
- Signed informed consent before any trial activities
You will not qualify if you...
- Presence of active implantable medical devices or other implanted electronic devices (e.g., pacemaker, defibrillator)
- Skin problems where stimulation electrodes are applied
- History of epileptic seizures within the past 2 years
- Severe cardiovascular disease or inability to perform heart rate variability analysis
- Serious ear diseases
- Documented vegetative neuropathy
- Unusual left ear shape preventing device use
- Presence of cochlear implant near stimulation site
- Impaired cognitive abilities
- Concurrent other malignancies except treated in-situ cervix carcinoma or non-melanoma skin carcinoma
- Pregnant or breastfeeding women
- Participation in another clinical study that could interfere
- Assessed as unable or unwilling to follow protocol requirements
- Deprived of liberty or under legal guardianship
AI-Screening
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Trial Site Locations
Total: 4 locations
1
Centre François Baclesse
Caen, France
Actively Recruiting
2
CHU CAEN
Caen, France
Not Yet Recruiting
3
Centre Oscar Lambret
Lille, France
Not Yet Recruiting
4
Centre Henri Becquerel
Rouen, France
Not Yet Recruiting
Research Team
F
François CHERIFI, Medical Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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