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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-A01527-40 | Registry Identifier | ID-RCB number |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | transcutaneous auricular vagus nerve stimulation (taVNS) |
|
| Control group | Placebo Comparator | placebo using the same device that does not deliver electrical stimulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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)". |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Measured at inclusion and on day 1 of each course before chemotherapy infusion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| François CHERIFI, Medical Doctor | Contact | 0231455050 | f.cherifi@baclesse.unicancer.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre François Baclesse | Recruiting | Caen | France |
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Randomized double-blind prospective multicenter study
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| 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) |
|
| The safety profile | Adverse events with regards to the use of the device, according to NCI-CTCAE V5.0 | 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 | 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, | At inclusion and during cycles 3 and 6 of chemotherapy (each cycle is 21 days) |
| Quality of life during chemotherapy | Quality of life scores according to the standardized self-questionnaire EORTC QLQ-C30 | 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 | 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) | 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 |
| CHU CAEN | Not yet recruiting | Caen | France |
|
| Centre Oscar Lambret | Not yet recruiting | Lille | France |
|
| Centre Henri Becquerel | Not yet recruiting | Rouen | France |
|
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D004066 | Digestive System Diseases |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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