Benefit of Transcutaneous Auricular Vagus Nerve Stimulation in Improving Quality of Life in First Line Treatment of Ovarian Cancer: (ESTANVO)

Centre Francois Baclesse

Status and phase: Enrolling; Phase 3

Conditions: Digestive System Disorders; First Line Chemotherapy; Ovarian Carcinoma

Treatments: Device: Placebo device; Device: transcutaneous auricular vagus nerve stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06817161

ESTANVO

2024-A01527-40 (Registry Identifier)

Details and patient eligibility

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

Full 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

Enrollment: 116 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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116 participants in 2 patient groups, including a placebo group

Experimental group

Experimental group

Description:

transcutaneous auricular vagus nerve stimulation (taVNS)

Treatment:

Device: transcutaneous auricular vagus nerve stimulation

Control group

Placebo Comparator group

Description:

placebo using the same device that does not deliver electrical stimulation

Treatment:

Device: Placebo device