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NCT Number: NCT06817161

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

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

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Key information

Conditions

Ovarian Carcinoma Adnexal Diseases Digestive System Diseases Digestive System Disorders Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications First Line Chemotherapy Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

CHU CAEN, Caen, France

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

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)

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

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

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

Secondary outcomes

  1. 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

    Heart Rate Variability (HRV) parameters through an electrocardiogram; as an exploratory complementary objective, for patients in Caen centres, HRV will also be measured using a Polar H10 type measuring device to determine two parameters SDDN and RMSSD

  2. The safety profile

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

    Adverse events with regards to the use of the device, according to NCI-CTCAE V5.0

  3. 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

    Number of daily taVNS stimulations and stimulation durations, taVNS (electrical) frequencies, according to ear device recordings

  4. - 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)

    • Blood concentrations of inflammatory markers : Neutrophil to Lymphocyte Ratio (NLR), CRP, Albumin,

  5. Quality of life during chemotherapy

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

    Quality of life scores according to the standardized self-questionnaire EORTC QLQ-C30

  6. 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

    Dose of chemotherapy delivered per time unit

  7. 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

    Progression-free survival (PFS) defined as time between randomization and first disease progression according to RECIST v1.1 criteria or death whatever cause (in the absence of progression)

Study contacts

Contact information is provided by the study sponsor or research team.

François CHERIFI, Medical Doctor

CONTACT

[email protected]

0231455050

Sponsors and collaborators

Lead sponsor

Centre Francois Baclesse

Other

Registry information

Official study title

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

Acronym: ESTANVO

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Feb 10, 2025
Registry last updated
Oct 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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