Efficacy of Auricular Acupuncture Therapy in the Prevention of CIPN in Breast Cancer

Официальное название

Efficacy of Auricular Acupuncture Therapy Via the Seirin Pyonex Needles in the Prevention of Chemotherapy-Induced Peripheral Neuropathy(CIPN) in Breast Cancer

Обзор

Evaluate the Efficacy of Auricular Acupuncture Therapy via the Seirin Pyonex Needles in the Prevention of Chemotherapy-Induced Peripheral Neuropathy in Breast Cancer

Подробное описание

This is a Phase II Randomised Controlled Clinical Trial to evaluate the efficacy of auricular acupuncture therapy via the Seirin Pyonex Needles in the prevention of chemotherapy-induced peripheral neuropathy in breast cancer.

Вмешательства

• Устройство Auricular acupuncture treatment
  Auricular acupuncture is an innovative intradermal acupuncture, which can directly use the meridian system of the ear skin to directly transmit the received stimulation to the lesion. Its stimulation time is long, and the amount of stimulation is strong. Studies have shown that needle pricking continuously delivers an adequate dose of acupuncture stimulation by continuously stimulating Aβ, Aδ, and/or C afferent fibers from the skin and transmitting them to the brain nucleus through the ventrolat
• Устройство Sham acupuncture group
  The treatment regimen is the same as that of the auricular acupuncture treatment group, but with a sham acupuncture (Seirin Pyonex Needles).

Первичные конечные точки

• Incidence of CIPN at the end of the 4th chemotherapy [Срок оценки: From date of randomization until the date of he fourth application of taxane chemotherapy (up to 12 weeks)]

Вторичные конечные точки (5)

• Incidence of CIPN at the end of the 3rd chemotherapy [Срок оценки: From date of randomization until the date of he fourth application of taxane chemotherapy (up to 12 weeks)]
• CIPN neurotoxicity change [Срок оценки: From date of randomization until the date of he fourth application of taxane chemotherapy (up to 12 weeks)]
• The degree of sensory impairment [Срок оценки: From date of randomization until the date of he fourth application of taxane chemotherapy (up to 12 weeks)]
• The pain intensity score [Срок оценки: From date of randomization until the date of he fourth application of taxane chemotherapy (up to 12 weeks)]
• The General Hospital Anxiety/Depression (HAD) [Срок оценки: From date of randomization until the date of he fourth application of taxane chemotherapy (up to 12 weeks)]

Критерии участия

Критерии включения

• Patients with breast cancer diagnosed with stage I-III;
• Planned to receive 4 cycles of taxane chemotherapy and have not taken neurostable drugs within three months;
• 18 years old≤ age≤ 75 years old, female;
• Subjects voluntarily participate in this trial and sign the informed consent form.

Критерии исключения

• Patients who have had acupuncture treatment in the past;
• After examination by a doctor, there is a local infection at or near the acupuncture site, which is not suitable for acupuncture.
• Platelets< 50,000/μL;
• Patients with CIPN≥1 grade 1 (NCI-CTCAE);
• Peripheral neuropathy or other neuropathic pain caused by diabetes mellitus or other factors related to HIV infection.

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

Открытое

Основная цель

Профилактика

Центры проведения

Китай · 1 центр

• Jiangsu Provincial People's Hospital — Нанкин

Идентификаторы

NCT: NCT07092111 · ACAA 01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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