Digestive System Disorders, First Line Chemotherapy, Ovarian Carcinoma
Conditions
Keywords
ovarian carinoma, parasympathetic, vagus nerve, transcutaneous auricular stimulation, quality of life, digestive symptoms
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
Detailed 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
Interventions
DEVICEtranscutaneous auricular vagus nerve stimulation
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)
DEVICEPlacebo 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)
Sponsors
Centre Francois Baclesse
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
Randomized double-blind prospective multicenter study
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| The safety profile | 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 |
| The compliance with the use of the device | 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 |
| - 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) | \- Blood concentrations of inflammatory markers : Neutrophil to Lymphocyte Ratio (NLR), CRP, Albumin, |
| 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 | 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 |
| The dose-intensity of chemotherapy in first-line treatment | During chemotherapy (6 cycles, each cycle is 21 days), so up to 5 months after inclusion | Dose of chemotherapy delivered per time unit |
| The progression-free survival | 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) |
| Quality of life during chemotherapy | 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 |
Countries
France
Contacts
Primary ContactFrançois CHERIFI, Medical Doctor
Outcome results
None listed