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

ConditionsOvarian CarcinomaFirst Line ChemotherapyDigestive System Disorders
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorCentre Francois Baclesse

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient ≥ 18 years old

ECOG 0-2

Histologically proven epithelial ovarian carcinoma

FIGO stage ≥ IIB

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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)

Treatment groups

116 Participants
are divided into 2 treatment groups
Group A: Experimental groupExperimental treatment 1 intervention
Group B: Control groupPlacebo comparator 1 intervention

Trial outcomes

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

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

Secondary outcomes

1

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

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

Time frame
Measured at inclusion and on day 1 of each course before chemotherapy infusion
2

The safety profile

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

Time frame
During chemotherapy (6 cycles, each cycle is 21 days), so up to 5 months after inclusion
3

The compliance with the use of the device

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

Time frame
During chemotherapy (6 cycles, each cycle is 21 days), so up to 5 months after inclusion
4

- The evolution of markers of inflammation (NLR, CRP, Albumin) during chemotherapy

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre Francois Baclesse

Lead sponsor

Source ClinicalTrials.gov
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