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Идёт набор NCT06772935

Electroacupuncture Treatment of Peripheral Neuropathy After Taxane Chemotherapy for Breast Cancer

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: Electro-acupuncture.
Кому может быть актуально
Состояния в реестре: Breast Cancer. Базовые параметры: 18 лет — 75 лет · Женщины.
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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

Electroacupuncture treatment of peripheral neuropathy after taxane chemotherapy for breast cancer

Подробное описание

Chemotherapy induced peripheral neuropathy has a significant impact on the integrity of chemotherapy cycle and quality of life of breast cancer patients. The latest research reports indicate that electroacupuncture has a certain therapeutic effect on peripheral neuropathy. In addition, existing studies have confirmed that the peripheral neuropathy of breast cancer induced by taxane is related to genetic factors. This study is based on electroacupuncture treatment of peripheral neuropathy induced by paclitaxel drugs, while screening SNPs related to peripheral neuropathy induced by taxane drugs, and establishing a prognostic model. Eligible patients diagnosed as stage I, II or IIIA breast cancer with peripheral neuropathy for at least 2 weeks were assessed by functional cancer treatment assessment/gynecological oncology group neurotoxicity scale (FACT/GOG-NTX) and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire CIPN Twenty Item Scale (EORTC QLQ-CIPN20). All items in the above two scales are scored using Likert's 5 and 4 levels. The researchers will temporarily divide the study into two groups, and if necessary, the researchers will add this group. Laboratory personnel are unaware of all clinical and outcome data.

Вмешательства

  • Поведенческое Electro-acupuncture
    A method of acupuncture that combines acupuncture with a certain frequency of electrical stimulation. Electrical stimulation is a mild level of stimulation intensity that is acceptable to the human body.

Первичные конечные точки

  • Functional Assessment of Cancer Therapy/Gynecologic Oncology Group Neurotoxicity Index （FACT/GOG-NTX） [Срок оценки: After enrollment, the first assessment of the scale will be conducted, followed by another assessment of the scale at the 4th and 8th week of treatment (7 days per week).]
Вторичные конечные точки (1)
  • The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire CIPN-20. [Срок оценки: After enrollment, the first assessment of the scale will be conducted, followed by another assessment of the scale at the 4th and 8th week of treatment (7 days per week).]

Критерии участия

Критерии включения

  • Breast cancer patients diagnosed by pathology;
  • EOOG score is 0 or 1;
  • The age range for enrollment is between 18 and 75 years old; ④ Accept chemotherapy regimens based on taxane drugs (alone or in combination);

⑤ Previously received taxane chemotherapy for more than 6 months;

⑥ According to the National Cancer Institute (NCI) Common Terminology for Adverse Events (CTCAE) 5.0, reporting CIPN symptoms of grade 1 or higher for more than 2 weeks;

⑦ Voluntarily participate in this clinical trial and sign the informed consent form;

  • Accept regular follow-up visits; ⑨ There is complete pathological data available.

Критерии исключения

  • Non breast cancer patients;
  • Received electroacupuncture treatment within 6 months prior to the start of the study;
  • Patients who experience intolerable toxic side effects during standard dose chemotherapy and terminate the chemotherapy cycle;
  • Prior to enrollment, there was a history of peripheral neuropathy;
  • Unstable heart disease or myocardial infarction within the first 6 months of the study;

⑥ Active skin diseases or surface skin ulcers or infections that cannot tolerate electroacupuncture treatment;

⑦ Uncontrolled epilepsy patients with uncontrolled seizures;

⑧ Merge with other malignant tumor patients;

⑨ Pregnancy and lactation period;

⑩ Refusal to join clinical trial patients

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
Лечение

Центры проведения

Китай · 1 центр
  • Qinghai University Affiliated Hospital — Xining

Идентификаторы

NCT: NCT06772935 · AHQU-2025001

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗