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

NCT06817161 | Recruiting Phase 3

• 2 other identifiers: ESTANVO2024-A01527-40
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Ovarian Carcinoma; First Line Chemotherapy; Digestive System Disorders

Keywords

ovarian carinoma; parasympathetic; vagus nerve; transcutaneous auricular stimulation; quality of life; digestive symptoms

Outcome Measures

Primary Outcomes (1)

• 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

  Score of the QoL dimension relating to digestive symptoms according to the EORTC QLQ-OV28 self-questionnaire

  At the beginning of Cycle 3 (each cycle is 21 days)".

Secondary Outcomes (7)

• The evolution of heart rate variability (HRV) during chemotherapy between the 2 groups of patients

  Measured at inclusion and on day 1 of each course before chemotherapy infusion

• The safety profile

  During chemotherapy (6 cycles, each cycle is 21 days), so up to 5 months after inclusion

• The compliance with the use of the device

  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

  At inclusion and during cycles 3 and 6 of chemotherapy (each cycle is 21 days)

• Quality of life during chemotherapy

  At inclusion, at courses 3 and 6 of chemotherapy (each cycle is 21 days)

Study Arms (2)

Experimental group

EXPERIMENTAL

transcutaneous auricular vagus nerve stimulation (taVNS)

Device: transcutaneous auricular vagus nerve stimulation

Control group

PLACEBO COMPARATOR

placebo using the same device that does not deliver electrical stimulation

Device: Placebo device

Interventions

transcutaneous auricular vagus nerve stimulation 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)

Experimental group

Placebo device 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)

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Francois Baclesse: lead

Study Sites (4)

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

MeSH Terms

Conditions

Ovarian Neoplasms; Digestive System Diseases

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Central Study Contacts

François CHERIFI, Medical Doctor

CONTACT

0231455050; f.cherifi@baclesse.unicancer.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized double-blind prospective multicenter study

Study Record Dates

• First Submitted: January 29, 2025
• First Posted: February 10, 2025
• Study Start: April 30, 2025
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: October 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)