针刺治疗激素受体阳性乳腺癌患者潮热的随机对照试验研究，A Randomized Controlled Trial of Acupuncture for the Management of Hot Flashes in Patients With Hormone Receptor-Positive Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Cranial fMRI Imaging Evaluation and Data Analysis
研究概览
简要总结
Hot flashes are among the most common and distressing adverse effects experienced by patients receiving endocrine therapy for hormone receptor-positive breast cancer. Hormone replacement therapy (HRT) and non-hormonal medications can alleviate symptoms but are limited by side effects and safety concerns, leading to poor adherence. Acupuncture, a traditional Chinese medical therapy involving percutaneous stimulation of specific acupoints, has shown potential to reduce the frequency and severity of hot flashes with minimal adverse events.
This randomized, parallel-controlled clinical trial aims to evaluate the efficacy and safety of acupuncture in managing hot flashes in postoperative breast cancer patients undergoing endocrine therapy. Sixty eligible patients with stage I-III hormone receptor-positive breast cancer will be randomly assigned in a 1:1 ratio to receive either true acupuncture or sham acupuncture, three times per week for eight weeks, followed by a 16-week follow-up period without acupuncture. Functional magnetic resonance imaging (fMRI) will be employed to explore neural mechanisms underlying acupuncture's effects, alongside assessments of hot flash frequency, quality of life (FACT-B+ES), sleep quality (PSQI), and serum biomarkers related to endocrine and neuropeptide regulation. The results are expected to provide evidence for the efficacy and central mechanisms of acupuncture in managing hot flashes in breast cancer patients.
详细描述
Background Breast cancer is the most prevalent malignancy among women. Advances in multimodal therapy-including surgery, chemotherapy, radiotherapy, endocrine therapy, and targeted therapy-have significantly improved prognosis and survival. However, endocrine therapy frequently induces vasomotor symptoms such as hot flashes, which severely impair quality of life.
Although hormone replacement therapy (HRT) and non-hormonal pharmacologic agents (e.g., SSRIs, anticonvulsants) can alleviate hot flashes, their safety and tolerability remain major limitations. Therefore, there is an urgent clinical need for safe and effective complementary interventions. Acupuncture has been widely used for symptom management in cancer patients due to its convenience, affordability, and safety. Multiple randomized controlled trials (RCTs) have demonstrated its effectiveness in reducing hot flashes and improving quality of life, with few adverse effects.
Functional magnetic resonance imaging (fMRI) studies further indicate that acupuncture can modulate brain regions related to thermoregulation and endocrine function. However, standardized clinical protocols and neuroimaging-based mechanistic studies for tumor-related hot flashes are still limited.
Study Design
This study adopts a single-center, randomized, parallel-controlled design. A total of 60 eligible patients will be randomly allocated (1:1) into two groups:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients aged 18 to 75 years. Histopathologically confirmed breast cancer, currently receiving endocrine therapy (e.g., selective estrogen receptor modulators and/or aromatase inhibitors, CDK4/6 inhibitors), with or without ovarian function suppression, for at least 4 weeks and ongoing at the time of enrollment.
- •Expected survival time > 6 months. Experiencing persistent hot flashes for at least 4 weeks, with a frequency of ≥14 episodes per week (≥2 per day) during the week prior to enrollment, and a Hot Flash Composite Score (HFCS) of 3-
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1:
- •0: Fully active, able to carry on all pre-disease performance without restriction;
- •Restricted in physically strenuous activity but ambulatory and able to carry out light work (e.g., housework, office work);
- •Ambulatory and capable of all self-care but unable to carry out any work activities; up and about more than 50% of waking hours;
- •Capable of only limited self-care; confined to bed or chair more than 50% of waking hours;
- •Completely disabled; cannot carry on any self-care; totally confined to bed or chair;
- •Dead. Willing and able to participate in the study and sign the informed consent form.
排除标准
- •Evidence of tumor metastasis, currently undergoing radiotherapy, chemotherapy, or having a planned surgery.
- •Use of selective serotonin reuptake inhibitors (SSRIs) and/or anticonvulsants or other pharmacologic agents for hot flash management within 4 weeks prior to study entry.
- •Unstable cardiac disease or myocardial infarction within 6 months prior to study initiation.
- •Recent initiation or modification of endocrine therapy within 1 week, or planned initiation or modification within 14 weeks.
- •History or risk of seizure of unclear etiology. Prior acupuncture treatment for hot flashes within 6 months before enrollment. Contraindications to MRI scanning. Pregnant or lactating women. Presence of uncontrolled active infection. Severe psychiatric disorders or family history of psychiatric or neurological diseases.
- •Withdrawal Criteria Failure to complete acupuncture treatment per protocol, making efficacy evaluation impossible.
- •Use of medications or treatments during the trial that may affect study outcomes.
- •Voluntary withdrawal from the study during treatment.
- •Discontinuation Criteria Serious adverse events, complications, or physiological changes during treatment that make continuation unsafe or impractical.
- •Loss to follow-up or death after enrollment. Participant's voluntary withdrawal at any stage of treatment.
结局指标
主要结局
Cranial fMRI Imaging Evaluation and Data Analysis
时间窗: 4 months
Functional magnetic resonance imaging (fMRI) of the brain will be performed before, during, and after treatment, as well as at the end of follow-up, to assess changes in brain structural and functional imaging characteristics.
次要结局
- Hot Flash Assessment(4 months)
- Quality of Life Assessment(4 months)
- Sleep Quality(4 months)
研究者
Shu Wang
director of breast center
Peking University People's Hospital