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
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
116
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)
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)
Centre François Baclesse
Caen, France
RECRUITINGCHU CAEN
Caen, France
NOT_YET_RECRUITINGCentre Oscar Lambret
Lille, France
NOT_YET_RECRUITINGCentre Henri Becquerel
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)".
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
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
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
- 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)
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Rouen, France
Quality of life during chemotherapy
Quality of life scores according to the standardized self-questionnaire EORTC QLQ-C30
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
Dose of chemotherapy delivered per time unit
Time frame: During chemotherapy (6 cycles, each cycle is 21 days), so up to 5 months after inclusion
The progression-free survival
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)
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