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Идёт набор NCT06314906

Electroacupuncture Plus Antiemetic Therapy for Chemotherapy-Induced Nausea and Vomiting in Patients With Breast Cancer

Фаза III С лечением Electroacupuncture Olanzapine-contained Four-drug Antiemetic Nausea and Vomiting

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: Electroacupuncture, Antiemetic Therapy, Sham electroacupuncture, Antiemetic Therapy.
Кому может быть актуально
Состояния в реестре: Electroacupuncture, Olanzapine-contained Four-drug Antiemetic, Nausea and Vomiting. Базовые параметры: 18 лет — 75 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
Китай
Следующий шаг
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Официальное название

Combining Electroacupuncture With Antiemetic Therapy for Preventing Chemotherapy-Induced Nausea and Vomiting in Patients With Breast Cancer: A Clinical Study

Обзор

This study explores the effectiveness of combining electroacupuncture with olanzapine-containing four-drug antiemetic therapy to mitigate chemotherapy-induced nausea and vomiting (CINV) in patients with breast cancer. The research aims to assess the adjunctive benefits of electroacupuncture in enhancing the antiemetic effects of conventional medication, particularly in the context of highly emetogenic chemotherapy regimens. By investigating the synergistic potential of these modalities, the study seeks to provide insights into optimizing supportive care strategies for patients with breast cancer undergoing intensive chemotherapy treatment.

Подробное описание

This study is a randomized controlled trial conducted in parallel groups, with blinding implemented. It aims to assess the effectiveness of combining electroacupuncture with standard quadruple antiemetic drugs for patients with breast cancer undergoing HEC.

Both study arms will be administered Olanzapine, Neurokinin-1 receptor antagonists, serotonin receptor antagonists, and dexamethasone at the commencement of HEC on Day 1. Subsequently, participants will be randomly assigned to receive either electroacupuncture or sham acupuncture.

Participants will be responsible for recording all instances of nausea and vomiting, as well as documenting the use of rescue antiemetic medications.

The study will evaluate primary and secondary outcomes, as well as monitor adverse events.

Вмешательства

  • Устройство Electroacupuncture
    Participants in this arm will undergo electroacupuncture sessions once daily from day 1 to day 4. Electrical stimulation will be administered for 30 minutes at alternating frequencies of 2/10Hz
  • Препарат Antiemetic Therapy
    Participants will receive oral olanzapine at a dose of 5 mg per day on days 1 through 4, along with NK1 receptor antagonist, 5HT3 receptor antagonist, and intravenous dexamethasone at a dose of 10 mg 30 minutes prior to chemotherapy on Day 1, followed by intravenous dexamethasone at a dose of 8 mg on days 2, 3, and 4 post-chemotherapy.
  • Устройство Sham electroacupuncture
    Participants assigned to this arm will receive sham electroacupuncture sessions daily from day 1 to day 4, mirroring the schedule of the experimental group
  • Препарат Antiemetic Therapy
    They will also receive the same antiemetic medications as the experimental group.

Первичные конечные точки

  • Proportion of Patients Free from Nausea Throughout Treatment [Срок оценки: 120 hours]

Критерии участия

Критерии включения

  • Patients aged 18 to 75 years, inclusive, from any nationality.
  • Patients diagnosed with early-stage breast cancer.
  • Eastern Cooperative Oncology Group performance status ranging from 0 to 2.
  • All patients must undergo highly emetogenic chemotherapy (HEC).
  • Adequate organ function.
  • Adequate contraception required for premenopausal women.

Критерии исключения

  • Scheduled to undergo chemotherapy between days 2 to 4 following HEC.
  • Received or is planned to receive abdominal radiation therapy within 1 week before Day 1 in cycle 1.
  • Significant medical or psychological conditions.
  • Presents with symptomatic primary or metastatic central nervous system malignancy causing nausea and/or vomiting.
  • Experiencing ongoing vomiting or nausea of grade 2 or higher according to Common Terminology Criteria for Adverse Events (CTCAE).
  • Any known allergies to the study drug, antiemetics, or dexamethasone.
  • Patients who have fear of electroacupuncture stimulation or are allergic to stainless steel needles.
  • Received acupuncture treatments for any conditions within 8 weeks prior to HEC.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Тройное слепое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • Second Hospital of Lanzhou University — Lanzhou

Идентификаторы

NCT: NCT06314906 · SHLU-2024001

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗