Using vagus nerve stimulation to improve quality of life in ovarian cancer treatment
Benefit of Transcutaneous Auricular Vagus Nerve Stimulation in Improving Quality of Life in First Line Treatment of Ovarian Cancer: the ESTANVO Randomized Trial
This study is testing if a new device that stimulates the vagus nerve can help improve the quality of life for women undergoing chemotherapy for ovarian cancer by reducing digestive problems.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 116 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Centre Francois Baclesse Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 4 sites (Caen and 3 other locations) |
| Trial ID | NCT06817161 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed epithelial ovarian carcinoma who are starting first-line chemotherapy.
Not a fit: Patients with active implantable medical devices or severe cardiovascular diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life for patients undergoing treatment for ovarian cancer.
How similar studies have performed: While the use of vagus nerve stimulation is gaining interest, this specific application in ovarian cancer treatment is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Caen and 3 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.