A Randomized Controlled Trial Study of Acupuncture in the Treatment 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
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change in acupuncture efficacy expectation assessment
研究概览
简要总结
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 functional magnetic resonance imaging technology.
详细描述
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.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Aged 18-75 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;
- •Vasomotor syndrome for at least 6 weeks;
- •Premenopausal or postmenopausal patients;
- •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 after chemotherapy (if any);
- •Eastern Cooperative Oncology Group score of 0-1 points.
- •Sign the informed consent and voluntarily participate in this clinical observation.
排除标准
- •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;
- •Unstable heart disease or myocardial infarction within 6 months prior to study start;
- •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;
- •Seizures of unknown likelihood or history of seizures;
- •Have used acupuncture for hot flashes within 6 months prior to the start of the study;
- •Pregnant or breastfeeding patients;
- •Apparent uncontrolled infection;
- •Mental illness or family history; neurological disorder or family history.
结局指标
主要结局
Change in acupuncture efficacy expectation assessment
时间窗: Baseline, 8,24 weeks later
Acupuncture efficacy expectation assessment scores will be assessed with acupuncture efficacy expectation assessment. The minimum value is 0 , and the maximum value is 20. The higher scores mean a better outcome.
Change of functional connectivity of whole brain
时间窗: Baseline, 8,24 weeks later
Functional connectivity will be measured with magnetic resonance imaging based on blood oxygen level dependence.
Change in cancer therapy functional assessment
时间窗: Baseline, 8,24 weeks later
Cancer therapy functional assessment scores will be assessed with Cancer Therapy Functional Assessment-Breast cancer, version 4.The minimum value is 0 , and the maximum value is 185. The higher scores mean a worse outcome.
Change of metabolism of glucose in the brain
时间窗: Baseline, 8,24 weeks later
Accumulation of 18F-fluorodeoxyglucose(18F-FDG) will be analyzed by time-related Positron emission tomography.
Change of hot flash severity
时间窗: Baseline, 8,24 weeks later
Hot flash severity will be assessed with hot flash scores each week. There are four levels of severity： Mild: Duration: Less than five minutes. Symptoms: warmth, discomfort, flushing. Moderate: Duration: Up to fifteen minutes. Symptoms: warmth in head, neck, ears, or body; tense, tight muscles; clammy skin; change in heart rate or rhythm; light sweating; dry mouth. Severe: Duration: Up to twenty minutes. Symptoms: Fever, sometimes like a crucible or burning sensation; change in heart rate or rhythm; feeling faint; headache; heavy sweating. Very severe: Duration: Up to forty-five minutes. Symptoms: boiling heat; constant sweating; trouble breathing; feeling faint, dizzy; leg cramps or feeling cramps; change in heart rate; stomach upset. The greater severity mean a worse outcome.
次要结局
- Change in sleep(Baseline, 8,24 weeks later)
研究者
Qianyan Liu
Principal Investgator
Nanjing University of Traditional Chinese Medicine