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

Официальное название

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

Обзор

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

Подробное описание

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

Вмешательства

• Устройство transcutaneous 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)
• Устройство Placebo 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)

Первичные конечные точки

• 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 [Срок оценки: At the beginning of Cycle 3 (each cycle is 21 days)".]

Вторичные конечные точки (7)

• The evolution of heart rate variability (HRV) during chemotherapy between the 2 groups of patients [Срок оценки: Measured at inclusion and on day 1 of each course before chemotherapy infusion]
• The safety profile [Срок оценки: During chemotherapy (6 cycles, each cycle is 21 days), so up to 5 months after inclusion]
• The compliance with the use of the device [Срок оценки: 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 [Срок оценки: At inclusion and during cycles 3 and 6 of chemotherapy (each cycle is 21 days)]
• Quality of life during chemotherapy [Срок оценки: At inclusion, at courses 3 and 6 of chemotherapy (each cycle is 21 days)]
• The dose-intensity of chemotherapy in first-line treatment [Срок оценки: During chemotherapy (6 cycles, each cycle is 21 days), so up to 5 months after inclusion]
• The progression-free survival [Срок оценки: 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]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Другое

Центры проведения

Франция · 4 центра

• Centre François Baclesse — Caen
• CHU CAEN — Caen
• Centre Oscar Lambret — Lille
• Centre Henri Becquerel — Rouen

Идентификаторы

NCT: NCT06817161 · ESTANVO · 2024-A01527-40

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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