Benefit of Transcutaneous Auricular Vagus Nerve Stimulation in Improving Quality of Life in First Line Treatment of Ovarian Cancer:
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: transcutaneous auricular vagus nerve stimulation, Placebo device.
- Who it may be relevant to
- Registry conditions: Ovarian Carcinoma, First Line Chemotherapy, Digestive System Disorders. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Benefit of Transcutaneous Auricular Vagus Nerve Stimulation in Improving Quality of Life in First Line Treatment of Ovarian Cancer: the ESTANVO Randomized Trial
Overview
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
Detailed description
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
Randomization between:
* Experimental group: transcutaneous auricular vagus nerve stimulation (taVNS) * Control group: placebo using the same device that does not deliver electrical stimulation
Interventions
- Device transcutaneous auricular vagus nerve stimulation
The intervention begins on the first day of chemotherapy and continues daily until 21 days after the end of chemotherapy (6 cycles). The dispositive is used every day at home, twice daily (during 30 minutes) - Device Placebo device
The intervention begins on the first day of chemotherapy and continues daily until 21 days after the end of chemotherapy (6 cycles). The dispositive is used every day at home, twice daily (during 30 minutes)
Primary outcome measures
- assess the 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 t [Time frame: At the beginning of Cycle 3 (each cycle is 21 days)".]
Secondary outcome measures (7)
- The evolution of heart rate variability (HRV) during chemotherapy between the 2 groups of patients [Time frame: Measured at inclusion and on day 1 of each course before chemotherapy infusion]
- The safety profile [Time frame: During chemotherapy (6 cycles, each cycle is 21 days), so up to 5 months after inclusion]
- The compliance with the use of the device [Time frame: During chemotherapy (6 cycles, each cycle is 21 days), so up to 5 months after inclusion]
- - The evolution of markers of inflammation (NLR, CRP, Albumin) during chemotherapy [Time frame: At inclusion and during cycles 3 and 6 of chemotherapy (each cycle is 21 days)]
- Quality of life during chemotherapy [Time frame: At inclusion, at courses 3 and 6 of chemotherapy (each cycle is 21 days)]
- The dose-intensity of chemotherapy in first-line treatment [Time frame: During chemotherapy (6 cycles, each cycle is 21 days), so up to 5 months after inclusion]
- The progression-free survival [Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Other
Study locations
France · 4 centers
- Centre François Baclesse — Caen
- CHU CAEN — Caen
- Centre Oscar Lambret — Lille
- Centre Henri Becquerel — Rouen
Identifiers
NCT: NCT06817161 · ESTANVO · 2024-A01527-40