NCT06817161招募中3 期
Benefit of Transcutaneous Auricular Vagus Nerve Stimulation in Improving Quality of Life in First Line Treatment of Ovarian Cancer: the ESTANVO Randomized Trial
Centre Francois Baclesse8 个研究点 分布在 1 个国家目标入组 116 人开始时间: 2025年4月30日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 116
- 试验地点
- 8
- 主要终点
- 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
研究概览
简要总结
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
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient ≥ 18 years old
- •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
排除标准
- •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
研究组 & 干预措施
Experimental group
Experimental
transcutaneous auricular vagus nerve stimulation (taVNS)
干预措施: transcutaneous auricular vagus nerve stimulation (Device)
Control group
Placebo Comparator
placebo using the same device that does not deliver electrical stimulation
干预措施: Placebo device (Device)
结局指标
主要结局
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
时间窗: 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
次要结局
- 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)
- The safety profile(During chemotherapy (6 cycles, each cycle is 21 days), so up to 5 months after inclusion)
- The compliance with the use of the device(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(At inclusion and during cycles 3 and 6 of chemotherapy (each cycle is 21 days))
- Quality of life during chemotherapy(At inclusion, at courses 3 and 6 of chemotherapy (each cycle is 21 days))
- 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)
- 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)
- 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)
- The safety profile(During chemotherapy (6 cycles, each cycle is 21 days), so up to 5 months after inclusion)
- The compliance with the use of the device(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(At inclusion and during cycles 3 and 6 of chemotherapy (each cycle is 21 days))
- Quality of life during chemotherapy(At inclusion, at courses 3 and 6 of chemotherapy (each cycle is 21 days))
- 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)
- 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)
研究者
研究点 (8)
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