Efficacy and Safety of Non Invasive Vagal Stimulation to Prevent Chemotherapy-induced Nausea in Patients With Breast Cancer Receiving Anthracycline and Cyclophosphamide Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 338
- 试验地点
- 8
- 主要终点
- Percentage of patients with significant nausea after the first chemotherapy cycle
研究概览
简要总结
Despite pharmaceutical innovations, chemotherapy induced nausea is frequent and largely participating to alter our patients quality of life.
Non invasive vagal stimulation is approved in other health issues, for example in headache or gastroparesis, with a reported benefit on nausea.
This study aims to analyse if a non invasive vagal stimulation could better prevent chemotherapy induced nausea, in addition to standard treatment, in breast cancer patients treated with cyclophosphamide and anthracycline.
详细描述
Despite pharmaceutical innovations, chemotherapy induced nausea is frequent and largely participating to alter our patients quality of life.
Non invasive vagal stimulation is approved in other health issues, for example in headache or gastroparesis, with a reported benefit on nausea.
This study aims to analyse if a non invasive vagal stimulation could better prevent chemotherapy induced nausea, in addition to standard treatment, in breast cancer patients treated with cyclophosphamide and anthracycline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
sham
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eastern Cooperative Oncology Group (ECOG) status 0 to 2
- •patient with breast cancer planned to receive Anthracycline and Cyclophosphamide chemotherapy
- •informed consent
- •compliance expected
- •social security affiliation
排除标准
- •nausea or vomiting 24h or less, before inclusion
- •Antiemetic drug intake in the last 72h before inclusion
- •Central nervous system metastasis
- •Daily alcohol intake
- •Prior chemotherapy
- •Cardiac arrythmia, severe heart failure
- •Device for sleep apnea
- •History of arterial or venous thrombosis, or thrombophlebitis
- •Vagal stimulation ongoing
- •Skin disease on the stimulation zone
- •Cochlear implant next to the stimulation zone
- •Unable to use the vagal stimulation device due to left ear unusual shape
- •Pregnant or breastfeeding women, or women of childbearing age without effective contraception
- •Documented allergy or contraindication to one of the antiemesis drugs required in the study
- •Protected adults (individuals under guardianship by court order)
- •Unable to read or write
研究组 & 干预措施
intervention
standard anti emetic treatment use of non invasive vagal stimulation twice a day from the day before chemotherapy till 4 days after, with a transcutaneous auricular device. This stimulation is to be done for the three first cycles of chemotherapy.
干预措施: non invasive auricular vagal stimulation (Device)
intervention
standard anti emetic treatment use of non invasive vagal stimulation twice a day from the day before chemotherapy till 4 days after, with a transcutaneous auricular device. This stimulation is to be done for the three first cycles of chemotherapy.
干预措施: usual medical treatment (Drug)
control
standard anti emetic treatment use of non invasive vagal stimulation twice a day from the day before chemotherapy till 4 days after, with a transcutaneous auricular sham device. This "stimulation" is to be done for the three first cycles of chemotherapy.
干预措施: usual medical treatment (Drug)
control
standard anti emetic treatment use of non invasive vagal stimulation twice a day from the day before chemotherapy till 4 days after, with a transcutaneous auricular sham device. This "stimulation" is to be done for the three first cycles of chemotherapy.
干预措施: sham stimulation (Device)
结局指标
主要结局
Percentage of patients with significant nausea after the first chemotherapy cycle
时间窗: 2 to 3 weeks
Nausea severity is graded daily from Day 1 (day of chemotherapy) to Day 5, using a numeric scale from 0 to 10. It is a patient reported outcome, patients using a diary. Significant nausea is a score of 2 or more.
次要结局
- Percentage of patients that did not vomit or use rescue emesis medication, from the first cycle of chemotherapy to day 5 after the third chemotherapy cycle.(7 to 12 weeks)
- Percentage of hospitalisations for emesis measured for the three first chemotherapy cycles.(7 to 12 weeks)
- Percentage of non planned visit to emergency care unit or general practioner or oncologist due to emesis, measured for the three first chemotherapy cycles.(7 to 12 weeks)
- Percentage of non anticipated hydratation with IV fluids measured for the three first chemotherapy cycles.(7 to 12 weeks)
- number and type of side effect during vagal stimulation safety(7 to 12 weeks)
- Percentage of patients with significant nausea after the second and the third chemotherapy cycle.(7 to 12 weeks)
- quality of life measurement using international validated questionnaire EORTC QLQ-C30 (quality of life questionnaire -C30), EORTC QLQ-BR23 (quality of life questionnaire for breast cancer), completed at the first three cycles(9 to 15 weeks)