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Идёт набор NCT04937309

Efficacy and Safety of Non Invasive Vagal Stimulation to Prevent Chemotherapy-induced Nausea

Без фазы С лечением Breast Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: non invasive auricular vagal stimulation, usual medical treatment, sham stimulation.
Кому может быть актуально
Состояния в реестре: Breast Cancer. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
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Официальное название

Efficacy and Safety of Non Invasive Vagal Stimulation to Prevent Chemotherapy-induced Nausea in Patients With Breast Cancer Receiving Anthracycline and Cyclophosphamide Chemotherapy

Обзор

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.

Подробное описание

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.

Вмешательства

  • Устройство non invasive auricular vagal stimulation
    Stimulation twice a day, beginning the day before until the fourth day after chemotherapy, for the three first chemotherapy cycles
  • Препарат usual medical treatment
    Standard anti emetic treatments to prevent emesis due to chemotherapy
  • Устройство sham stimulation
    Stimulation twice a day, beginning the day before until the fourth day after chemotherapy, for the three first chemotherapy cycles, with a sham device

Первичные конечные точки

  • Percentage of patients with significant nausea after the first chemotherapy cycle [Срок оценки: 2 to 3 weeks]
Вторичные конечные точки (7)
  • Percentage of patients with significant nausea after the second and the third chemotherapy cycle. [Срок оценки: 7 to 12 weeks]
  • 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. [Срок оценки: 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. [Срок оценки: 7 to 12 weeks]
  • Percentage of non anticipated hydratation with IV fluids measured for the three first chemotherapy cycles. [Срок оценки: 7 to 12 weeks]
  • Percentage of hospitalisations for emesis measured for the three first chemotherapy cycles. [Срок оценки: 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 [Срок оценки: 9 to 15 weeks]
  • number and type of side effect during vagal stimulation safety [Срок оценки: 7 to 12 weeks]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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
  • Vagotomy
  • 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

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
Четверное слепое
Основная цель
Поддерживающая терапия

Центры проведения

Франция · 8 центров
  • CH BLOIS — Blois
  • Chru Morvan — Brest
  • CORT37 — Chambray-lès-Tours
  • Ch Chateauroux — Châteauroux
  • Clinique Victor Hugo — Le Mans
  • Ch Orleans — Orléans
  • Ch Chinon — Saint-Benoît-la-Forêt
  • CHRU Bretonneau — Tours

Идентификаторы

NCT: NCT04937309 · DR210090_SILENCE

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗