Study of Acupuncture in the Treatment of Hot Flashes in Patients With Hormone Receptor-positive Breast Cancer.

Официальное название

A Randomized Controlled Trial Study of Acupuncture in the Treatment of Hot Flashes in Patients With Hormone Receptor-positive Breast Cancer.

Обзор

This study intends to further evaluate the efficacy of acupuncture by comparing the intervention effects of different acupuncture treatment regimens on hot flashes in breast cancer ; and to explore the central effect regulation mechanism of acupuncture intervention on hot flashes based on integrated PET/MRI technology.

Подробное описание

This topic combines the theory of "unblocking the governor and warming the yang" with the important findings of modern research, that is, the important mechanism of the spine in the pathogenesis of breast cancer, and innovatively proposes the technique of unblocking the governor and treating the spine. Prospective clinical intervention research in rehabilitation, objectively evaluate the clinical efficacy, advantages and disadvantages of this technology, so as to effectively break through the current application dilemma of acupuncture and bone-setting manipulation in tumor diseases.

Вмешательства

• Другое Acupuncture treatment
  Acupoint selection: 4 general points + syndrome differentiation acupoints (select or replace 2-4 acupoints according to symptom 1, select 1-2 acupoints according to symptom 2 and symptom 3), and adjust acupoints according to symptoms every week. Frequency: 3 times a week (once every other day) for a total of 8 weeks of continuous treatment. Operation: Use a one-time sterile acupuncture needle (0.30×40mm, Huatuo brand), insert the needle 0.5 inch along the anatomical position, level up and reli
• Другое Sham acupuncture treatment
  Acupoint selection: According to the selected acupoints of the electroacupuncture group, 5-7 positions were selected at the non-meridian and non-acupoint points(points with less nerve distribution, sparseness, and rich muscles). Frequency: 3 times a week (once every other day) for a total of 8 weeks of continuous treatment. Operation: ① Shallow needling scheme: use a disposable sterile acupuncture needle, insert the needle 0.2 inch, without twisting, and keep the needle for 20 minutes. ②Non-in

Первичные конечные точки

• Change in cancer therapy functional assessment [Срок оценки: Baseline, 8, 12，24 weeks later]
• Change in acupuncture efficacy expectation assessment [Срок оценки: Baseline, 8, 12，24 weeks later]
• Change of functional connectivity of whole brain [Срок оценки: Baseline, 8, 12，24 weeks later]
• Change of metabolism of glucose in the brain [Срок оценки: Baseline, 8, 12，24 weeks later]
• Change of hot flash severity [Срок оценки: Baseline, 8, 12，24 weeks later]

Вторичные конечные точки (1)

• Change in sleep [Срок оценки: Baseline, 8, 12，24 weeks later]

Критерии участия

Критерии включения

• Aged 30-75 years old;
• Adjuvant hormone therapy (eg, tamoxifen and/or aromatase inhibitors) with or without ovarian function suppression has been administered for at least 4 weeks and is currently on treatment;
• Patients with persistent hot flashes for at least 4 weeks and with a frequency of more than 14 hot flashes per week (2 times per day) in the week before inclusion in the study, the weekly average hot flash composite score is 3-4;
• Patients after surgery and chemotherapy (if any);
• Eastern Cooperative Oncology Group score of 0-1 points.
• Sign the informed consent and participate in the clinical observation voluntarily.

Критерии исключения

• Tumor metastases, undergoing chemoradiotherapy or planning surgery;
• Pharmacological intervention for hot flashes with hot flash treatment drugs such as selective serotonin reuptake inhibitors (SSRIs) and/or anticonvulsants for at least 4 weeks prior to study initiation;
• Patients receiving phytoestrogens, tibolone or analogs, verapril, or specific homeopathic medicines;
• Started or changed adjuvant hormone therapy within the past week, or who planned to start or change adjuvant hormone therapy in the past 14 weeks, pregnant or breastfeeding patients;
• Bleeding or coagulation disorders with obvious uncontrolled infection
• Psychiatric illness or family history; neurological disorder or family history; seizure possibility or history of seizures.

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

• Jiangsu Province Hospital of Traditional Chinese Medcine — Нанкин

Идентификаторы

NCT: NCT05613504 · 2022JC-55-1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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