Using vagus nerve stimulation to improve quality of life in ovarian cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effects of transcutaneous auricular vagus nerve stimulation (taVNS) on the quality of life of patients undergoing first-line chemotherapy for ovarian cancer. Participants will be randomly assigned to receive either active taVNS or a placebo device that does not deliver electrical stimulation. The primary focus is on alleviating digestive symptoms associated with chemotherapy. The study aims to determine if stimulating the parasympathetic nervous system can enhance overall well-being during treatment.

Why it matters

Who can join: the full rules

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 or adjuvant)
* Patient affiliated to an appropriate social security system
* Patient who has signed informed consent obtained before any trial related activities

Exclusion Criteria:

* 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's running

• Centre François Baclesse
  Caen, France Recruiting
• Chu Caen
  Caen, France Not yet recruiting
• Centre Oscar Lambret
  Lille, France Not yet recruiting
• Centre Henri Becquerel
  Rouen, France Not yet recruiting

Study contacts

• Study coordinator: François CHERIFI, Medical Doctor
• Email: f.cherifi@baclesse.unicancer.fr
• Phone: 0231455050

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.