Phase
Condition
Ulcers
Carcinoma
Gastrointestinal Diseases And Disorders
Treatment
Placebo device
transcutaneous auricular vagus nerve stimulation
Clinical Study ID
Ages > 18 Female
Study Summary
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
Study Description
Connect with a study center
CHU CAEN
Caen,
FranceSite Not Available
Centre François Baclesse
Caen,
FranceActive - Recruiting
Centre Oscar Lambret
Lille,
FranceSite Not Available
Centre Henri Becquerel
Rouen,
FranceSite 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.